<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255981</url>
  </required_header>
  <id_info>
    <org_study_id>Neijing Ophthalmology</org_study_id>
    <nct_id>NCT02255981</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture in Macular Diseases</brief_title>
  <acronym>AMAD</acronym>
  <official_title>¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Escuela Neijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Escuela Neijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-arm study designed to assess the efficacy of acupuncture (Traditional&#xD;
      Chinese Medicine) for chronic macular diseases of several types. All participants received&#xD;
      acupuncture and massage and there is not a placebo group because it is not considered a good&#xD;
      form to evaluate in Chinese Medicine due to, acupuncturing being a procedure is not as blind&#xD;
      as is desired. As a control of the results in this trial, the outcomes could be contrasted&#xD;
      against those reported in known medical publications and against expectations of the progress&#xD;
      of the damage without treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background.&#xD;
&#xD;
      WHO has included retinal diseases between conditions treatable by acupuncture and Traditional&#xD;
      Chinese Medicine (TCM) has been used for retinal diseases in hospitals of China and in other&#xD;
      parts of the world many years ago. Acupuncture and periocular massage act stimulating the&#xD;
      vital energy to restore the normal function of the body.&#xD;
&#xD;
      Currently, most common treatments in Western Medicine, anti-VEGF, only are indicated for less&#xD;
      than 10 percent of cases, which are the wet form or neovascular of AMD (NV-AMD) and they have&#xD;
      restrictions for use, additionally, their cost and requirements are limiting for populations&#xD;
      in all countries.&#xD;
&#xD;
      Objectives. The primary purpose of this study is to confirm the objective response among&#xD;
      subjects with macular diseases treated with acupuncture and massage. The results of&#xD;
      conventional treatment are published in similar trials and some of our patients have had&#xD;
      intraocular injections previously.&#xD;
&#xD;
      It is important to feature the affordability of this therapy for low-income populations that&#xD;
      do not have specialists or facilities nearby or for many governments that complain about the&#xD;
      huge burden of the treatment of there diseases. In Colombia, the average cost of each&#xD;
      intraocular injection by the time of this trial was about US 3.500 and it can be repeated&#xD;
      every month, it requires a retina specialist and a surgical room, that is out of reach for&#xD;
      many people in the country.&#xD;
&#xD;
      We did not calculate the costs of our treatment because the research team did voluntary&#xD;
      labor, and the devices are at a very low cost, about US 0.50 in each session. Acupuncture&#xD;
      treatment does not require special facilities as surgical rooms required in treatments with&#xD;
      intraocular injections. The participants were not paid, they came from different economic&#xD;
      conditions, some better, others from poorest neighborhoods or some from the rural areas.&#xD;
&#xD;
      This study includes 3 phases: Selection, Treatment, and Follow-up phases.&#xD;
&#xD;
      The selection phase included confirmed diagnosis by clinical register and OCT, Ophthalmologic&#xD;
      assessment, and consent of the patient.&#xD;
&#xD;
      Macular diseases. In this trial, some patients had NV AMD in one or both eyes, dry AMD,&#xD;
      myopic maculopathy or Stargardt disease. For TCM it is possible to treat all as damage of&#xD;
      similar category.&#xD;
&#xD;
      Why no control group. There was no control group due to ethical reasons, leave the impairment&#xD;
      without treatment in these mostly very sad persons. The second reason is the well-known&#xD;
      difficulty to mask a procedure like acupuncture. another third reason is the possibility to&#xD;
      contrast the results of this trial with those of similar studies conducted in eyes with&#xD;
      conventional treatment.&#xD;
&#xD;
      In the phase of treatment, Patients received a session of acupuncture according to a standard&#xD;
      protocol of points, and a periocular massage that was taught to the patient to be&#xD;
      self-performed daily. The acupuncture sessions were scheduled every week initially, the&#xD;
      evaluation of response was realized every 2 months by ophthalmologic exam and was asked to&#xD;
      participants an optical coherence tomography (OCT) that would be realized every 6 months.&#xD;
      Depending on the results of ophthalmologic assessment the sessions were extended gradually to&#xD;
      every 2, 3, 5 until 13 weeks. Although tomographic assessments had been scheduled every 6&#xD;
      months, only a few of the participants accomplish with that due to economic limitations.&#xD;
      Treatment continued until 24 months&#xD;
&#xD;
      All patients in the follow-up phase of this trial were monitored according to the Safety&#xD;
      Follow-up protocol and the defined procedures and evaluations.&#xD;
&#xD;
      The final results were collected and analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Interventional, no randomized, no masking</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking is neither accurate nor reliable in a procedure such as acupuncture or massage.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study</measure>
    <time_frame>Baseline, 2 months and every 2 months until month 24.</time_frame>
    <description>The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA).&#xD;
VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye.&#xD;
Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart.</measure>
    <time_frame>24 months from baseline.</time_frame>
    <description>Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is &quot;legal blindness&quot;. Blindness is considered VA worse than 3/60.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart</measure>
    <time_frame>Baseline and at end of study (up to 2 years)</time_frame>
    <description>The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.</measure>
    <time_frame>2 years</time_frame>
    <description>&quot;Improved&quot; was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). &quot;Stable&quot; was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. &quot;Lost&quot; was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)</measure>
    <time_frame>Baseline and end of study (up to 2 years)</time_frame>
    <description>At study entry, major complaints of patients were collected by survey. Participants also completed a survey at the middle and at the end of the trial. This data is the percentage of participants that reported changes to the main visual complaints that they considered significant in their lives compared with the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.</measure>
    <time_frame>2 years</time_frame>
    <description>To report this measure the adverse events or risks had to be observed carefully and registered in order to care for the safety and to accomplish regulations of any treatment or medical intervention. For this procedure, the usual risks are some adverse events as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other serious events related or not with the therapeutic procedure, had to be reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <condition>Stargardt Disease</condition>
  <condition>Macular Dystrophy</condition>
  <arm_group>
    <arm_group_label>Acupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months&#xD;
.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture and massage</intervention_name>
    <description>Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.&#xD;
Periocular massage is taught and is practiced daily by the patient him or herself.</description>
    <arm_group_label>Acupuncture group</arm_group_label>
    <other_name>Traditional Chinese Medicine:( TCM)</other_name>
    <other_name>acupuncture chinese style</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Clinical diagnosis of Macular Disease.&#xD;
&#xD;
               -  The patient must accept treatment with acupuncture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luz H Gutierrez, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Escuela Neijing Colombia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose L Padilla, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hispano American Acupuncture Association-Beijing 84, Madrid, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José R Gutiérrez, MD, Opht</last_name>
    <role>Study Chair</role>
    <affiliation>Sociedad Colombiana de Oftalmología</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Libia V Ferrer, Tech TCM</last_name>
    <role>Study Chair</role>
    <affiliation>Escuela Neijing Colombia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergio L Pineda</last_name>
    <role>Study Chair</role>
    <affiliation>Escuela Neijing Colombia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IPS Fundación Neijing</name>
      <address>
        <city>Guarne</city>
        <state>Antioquia</state>
        <zip>0000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Fundación Neijing</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>0000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <results_reference>
    <citation>Gutierrez L, Pineda S, Gutierrez R, Ferrer L. Acupuncture in Macular Diseases (AMAD) No published yet</citation>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>November 29, 2017</results_first_submitted>
  <results_first_submitted_qc>March 31, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 1, 2020</results_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Escuela Neijing</investigator_affiliation>
    <investigator_full_name>Dra. Luz Helena Gutiérrez C</investigator_full_name>
    <investigator_title>Luz Gutierrez Physician, MPH, Escuela Neijing, Research Coordinator.</investigator_title>
  </responsible_party>
  <keyword>macular degeneration, acupuncture, OCT, Stargardt, dystrophy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Stargardt Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>sex, age, ophthalmologic diagnostic data (medical examination, images) diagnostic signs on Traditional Chinese Medicine (TCM), number of sessions, visual outcome, hazards, previous treatment. Individual participant data that underlie the results reported will be shared after deidentification</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Inmediate following publication and no end term.</ipd_time_frame>
    <ipd_access_criteria>Any</ipd_access_criteria>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Project was announced to ophthalmologists asking them to refer patients. Very few arrived by reference and most entered by personal interest. Study was conducted in Medical consultation site of Neijing School, in Medellín, Colombia The recruitment period was between April 2013 and May 2014.</recruitment_details>
      <pre_assignment_details>35 patients were eligible, 2 refused to participate, 29 completed follow up. There was not an assignment, all received the same treatment although the diagnostics comprised different forms of macular damage it was pre-specified to analyze them as a single group for the Outcomes 2 eyes were excluded: 1 blind and 1 with retinal detachment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Acupuncture &amp; Macular Damage</title>
          <description>Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself&#xD;
.&#xD;
Acupuncture Traditional Chinese Medicine (TCM): Treatment consist in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33">Both eyes of each patient were included except 2 that not were treatable</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29">2 eyes of the final 29 subjects were excluded.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>35 patients met inclusion criteria, 33 consented to participate, 4 dropped off, 29 ended the 24 month period of treatment and observation</population>
      <group_list>
        <group group_id="B1">
          <title>Acupuncture &amp; Macular Damage</title>
          <description>Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself&#xD;
.&#xD;
Acupuncture Traditional Chinese Medicine (TCM): Treatment consist in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.9" spread="11.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study</title>
        <description>The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA).&#xD;
VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye.&#xD;
Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline.</description>
        <time_frame>Baseline, 2 months and every 2 months until month 24.</time_frame>
        <population>The primary analysis includes only patients who completed the 24-month exam. The improvement in this outcome is measured on eyes which had a vision gain in lines of the Snellen chart.</population>
        <group_list>
          <group group_id="O1">
            <title>Change in VA From Baseline to the End of Study</title>
            <description>There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together</description>
          </group>
        </group_list>
        <measure>
          <title>Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study</title>
          <description>The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA).&#xD;
VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye.&#xD;
Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline.</description>
          <population>The primary analysis includes only patients who completed the 24-month exam. The improvement in this outcome is measured on eyes which had a vision gain in lines of the Snellen chart.</population>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eyes which improved VA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyes with stable VA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyes which lost VA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart.</title>
        <description>Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is &quot;legal blindness&quot;. Blindness is considered VA worse than 3/60.</description>
        <time_frame>24 months from baseline.</time_frame>
        <population>All participants received the same treatment in a treat and extend regimen with an ophthalmological review every 2 months for 2 years. Data of VA from baseline to the end of the study were compared to assess Improvement or worsening. Improved means eyes with a better score of lines, stable means equal VA and worse is a loss of lines seen.</population>
        <group_list>
          <group group_id="O1">
            <title>VA Measured at Snellen Chart at the Beginning of the Study</title>
            <description>In all participants, VA was measured at baseline. The category of visual impairment according to WHO, ICD-10 is presented below.</description>
          </group>
          <group group_id="O2">
            <title>VA Measured at Snellen Chart at the End of the Study</title>
            <description>VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.</description>
          </group>
        </group_list>
        <measure>
          <title>Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart.</title>
          <description>Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is &quot;legal blindness&quot;. Blindness is considered VA worse than 3/60.</description>
          <population>All participants received the same treatment in a treat and extend regimen with an ophthalmological review every 2 months for 2 years. Data of VA from baseline to the end of the study were compared to assess Improvement or worsening. Improved means eyes with a better score of lines, stable means equal VA and worse is a loss of lines seen.</population>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blindness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart</title>
        <description>The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.</description>
        <time_frame>Baseline and at end of study (up to 2 years)</time_frame>
        <population>In AMD patients, some had a form in one eye and other in the fellow. &quot;Improved&quot; means the eyes which improved based on the number of letters gained in the ETDRS chart over the baseline and maintained for the end of the study. &quot;Stable&quot; if the number of letters is almost the same and &quot;lost&quot; if it was reduced.</population>
        <group_list>
          <group group_id="O1">
            <title>All Eyes Which Received Acupunture for 24 Months</title>
            <description>The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used.&#xD;
There were 22 eyes diagnosed with NV AMD, 23 eyes with no NV AMD, 8 eyes with macular dystrophy, and 3 eyes with Myopic degeneration. 2 eyes of all participants were excluded due to its status, one blind and one with retinal detachment. Although the observation collected the data for each macular disease form, the objective of the trial was not to compare between types of the disease and the results are grouped for the total of eyes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart</title>
          <description>The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.</description>
          <population>In AMD patients, some had a form in one eye and other in the fellow. &quot;Improved&quot; means the eyes which improved based on the number of letters gained in the ETDRS chart over the baseline and maintained for the end of the study. &quot;Stable&quot; if the number of letters is almost the same and &quot;lost&quot; if it was reduced.</population>
          <units>Letters on ETDRS scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Letters seen at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5178" spread="33.7127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Letters seen at the end of study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5714" spread="30.2450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3571" spread="18.8684"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.&#xD;
Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.&#xD;
It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up.</p_value_desc>
            <method>t-test, 1 sided</method>
            <method_desc>From this estimation, it is induced that there are differences in results before and after the treatment.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>15.392</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.</estimate_desc>
            <other_analysis_desc>The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.</title>
        <description>&quot;Improved&quot; was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). &quot;Stable&quot; was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. &quot;Lost&quot; was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)</description>
        <time_frame>2 years</time_frame>
        <population>Patients with AMD can have both eyes with neovascular AMD or NV-AMD in one of the eyes and No NA-AMD in the fellow.</population>
        <group_list>
          <group group_id="O1">
            <title>Acupuncture Group Eyes With NV AMD</title>
            <description>Patients with neovascular membrane treated with Acupuncture and massage who improved vision (AV).&#xD;
Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months&#xD;
Acupuncture has been used for retinal diseases in hospitals of China and in other parts of the world. Some patients in this study had one or both eyes with AMD classified as Neovascular AMD by OCT and retinologist examination. In this group were analyzed 22 eyes of 13 patients, Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.&#xD;
Periocular massage is taught and is practiced daily by the patient him or herself.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.</title>
          <description>&quot;Improved&quot; was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). &quot;Stable&quot; was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. &quot;Lost&quot; was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)</description>
          <population>Patients with AMD can have both eyes with neovascular AMD or NV-AMD in one of the eyes and No NA-AMD in the fellow.</population>
          <units>eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)</title>
        <description>At study entry, major complaints of patients were collected by survey. Participants also completed a survey at the middle and at the end of the trial. This data is the percentage of participants that reported changes to the main visual complaints that they considered significant in their lives compared with the baseline.</description>
        <time_frame>Baseline and end of study (up to 2 years)</time_frame>
        <population>All the participants who had a follow up for 24 months filled a survey about their complains and limitation in daily life at the beginning, in the middle time and at the end of the study. The measure is the number of patients who reported improvement.</population>
        <group_list>
          <group group_id="O1">
            <title>Acupuncture Group</title>
            <description>Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months&#xD;
Acupuncture and massage: Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement. A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.&#xD;
Periocular massage is taught and is practiced daily by the patient him or herself.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)</title>
          <description>At study entry, major complaints of patients were collected by survey. Participants also completed a survey at the middle and at the end of the trial. This data is the percentage of participants that reported changes to the main visual complaints that they considered significant in their lives compared with the baseline.</description>
          <population>All the participants who had a follow up for 24 months filled a survey about their complains and limitation in daily life at the beginning, in the middle time and at the end of the study. The measure is the number of patients who reported improvement.</population>
          <units>percentage of participants improved</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.</title>
        <description>To report this measure the adverse events or risks had to be observed carefully and registered in order to care for the safety and to accomplish regulations of any treatment or medical intervention. For this procedure, the usual risks are some adverse events as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other serious events related or not with the therapeutic procedure, had to be reported.</description>
        <time_frame>2 years</time_frame>
        <population>Participants who suffered some adverse event as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other events related or not with the therapeutic procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Adverse Events</title>
            <description>By law, and by the protocol of study the adverse events were monitored. In acupuncture, the risks are not frequent and mainly they can consist of pain in the site of insertion of the needle, minimal bleeding or ecchymosis.&#xD;
When the observed adverse events exceed the expectations, should have been reported, i.e., moderate to severe pain, bleeding that is more than a drop, or ecchymosis bigger than 5 millimeters in diameter.&#xD;
Similarly, was monitored any trouble related or not with the treatment as serious adverse events and mortality.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.</title>
          <description>To report this measure the adverse events or risks had to be observed carefully and registered in order to care for the safety and to accomplish regulations of any treatment or medical intervention. For this procedure, the usual risks are some adverse events as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other serious events related or not with the therapeutic procedure, had to be reported.</description>
          <population>Participants who suffered some adverse event as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other events related or not with the therapeutic procedure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event were carefully observed by 2 years</time_frame>
      <desc>As adverse event in acupuncture is considered bleeding, haematomas, injury to vital organs</desc>
      <group_list>
        <group group_id="E1">
          <title>All Study Participants</title>
          <description>Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion plus Periocular massage.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Participants were limited by lack of knowing and credibility of ophthalmologists in TCM OCTs every 6 months was not possible for some due to the cost. Some patients had independent evaluation and their ophthalmologist appreciated the results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Researcher</name_or_title>
      <organization>Escuela Neijing</organization>
      <phone>5744211000</phone>
      <email>lhgut2001@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255981
org study id: Neijing Ophthalmology
nct id: NCT02255981
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a single-arm study designed to assess the efficacy of acupuncture (Traditional
      Chinese Medicine) for chronic macular diseases of several types. All participants received
      acupuncture and massage and there is not a placebo group because it is not considered a good
      form to evaluate in Chinese Medicine due to, acupuncturing being a procedure is not as blind
      as is desired. As a control of the results in this trial, the outcomes could be contrasted
      against those reported in known medical publications and against expectations of the progress
      of the damage without treatment.
Background.

      WHO has included retinal diseases between conditions treatable by acupuncture and Traditional
      Chinese Medicine (TCM) has been used for retinal diseases in hospitals of China and in other
      parts of the world many years ago. Acupuncture and periocular massage act stimulating the
      vital energy to restore the normal function of the body.

      Currently, most common treatments in Western Medicine, anti-VEGF, only are indicated for less
      than 10 percent of cases, which are the wet form or neovascular of AMD (NV-AMD) and they have
      restrictions for use, additionally, their cost and requirements are limiting for populations
      in all countries.

      Objectives. The primary purpose of this study is to confirm the objective response among
      subjects with macular diseases treated with acupuncture and massage. The results of
      conventional treatment are published in similar trials and some of our patients have had
      intraocular injections previously.

      It is important to feature the affordability of this therapy for low-income populations that
      do not have specialists or facilities nearby or for many governments that complain about the
      huge burden of the treatment of there diseases. In Colombia, the average cost of each
      intraocular injection by the time of this trial was about US 3.500 and it can be repeated
      every month, it requires a retina specialist and a surgical room, that is out of reach for
      many people in the country.

      We did not calculate the costs of our treatment because the research team did voluntary
      labor, and the devices are at a very low cost, about US 0.50 in each session. Acupuncture
      treatment does not require special facilities as surgical rooms required in treatments with
      intraocular injections. The participants were not paid, they came from different economic
      conditions, some better, others from poorest neighborhoods or some from the rural areas.

      This study includes 3 phases: Selection, Treatment, and Follow-up phases.

      The selection phase included confirmed diagnosis by clinical register and OCT, Ophthalmologic
      assessment, and consent of the patient.

      Macular diseases. In this trial, some patients had NV AMD in one or both eyes, dry AMD,
      myopic maculopathy or Stargardt disease. For TCM it is possible to treat all as damage of
      similar category.

      Why no control group. There was no control group due to ethical reasons, leave the impairment
      without treatment in these mostly very sad persons. The second reason is the well-known
      difficulty to mask a procedure like acupuncture. another third reason is the possibility to
      contrast the results of this trial with those of similar studies conducted in eyes with
      conventional treatment.

      In the phase of treatment, Patients received a session of acupuncture according to a standard
      protocol of points, and a periocular massage that was taught to the patient to be
      self-performed daily. The acupuncture sessions were scheduled every week initially, the
      evaluation of response was realized every 2 months by ophthalmologic exam and was asked to
      participants an optical coherence tomography (OCT) that would be realized every 6 months.
      Depending on the results of ophthalmologic assessment the sessions were extended gradually to
      every 2, 3, 5 until 13 weeks. Although tomographic assessments had been scheduled every 6
      months, only a few of the participants accomplish with that due to economic limitations.
      Treatment continued until 24 months

      All patients in the follow-up phase of this trial were monitored according to the Safety
      Follow-up protocol and the defined procedures and evaluations.

      The final results were collected and analyzed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Interventional, no randomized, no masking
primary purpose: Treatment
masking: None (Open Label)
masking description: Masking is neither accurate nor reliable in a procedure such as acupuncture or massage.
measure: Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study
time frame: Baseline, 2 months and every 2 months until month 24.
description: The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA).
VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye.
Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline.
measure: Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart.
time frame: 24 months from baseline.
description: Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is "legal blindness". Blindness is considered VA worse than 3/60.
measure: Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart
time frame: Baseline and at end of study (up to 2 years)
description: The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.
measure: Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.
time frame: 2 years
description: "Improved" was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). "Stable" was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. "Lost" was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)
measure: Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)
time frame: Baseline and end of study (up to 2 years)
description: At study entry, major complaints of patients were collected by survey. Participants also completed a survey at the middle and at the end of the trial. This data is the percentage of participants that reported changes to the main visual complaints that they considered significant in their lives compared with the baseline.
measure: Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.
time frame: 2 years
description: To report this measure the adverse events or risks had to be observed carefully and registered in order to care for the safety and to accomplish regulations of any treatment or medical intervention. For this procedure, the usual risks are some adverse events as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other serious events related or not with the therapeutic procedure, had to be reported.
arm group label: Acupuncture group
arm group type: Experimental
description: Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months
.
intervention type: Other
intervention name: Acupuncture and massage
description: Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.
Periocular massage is taught and is practiced daily by the patient him or herself.
arm group label: Acupuncture group
other name: Traditional Chinese Medicine:( TCM)
other name: acupuncture chinese style
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Luz H Gutierrez, MD, MPH
role: Principal Investigator
affiliation: Escuela Neijing Colombia
last name: Jose L Padilla, MD
role: Study Director
affiliation: Hispano American Acupuncture Association-Beijing 84, Madrid, Spain
last name: José R Gutiérrez, MD, Opht
role: Study Chair
affiliation: Sociedad Colombiana de Oftalmología
last name: Libia V Ferrer, Tech TCM
role: Study Chair
affiliation: Escuela Neijing Colombia
last name: Sergio L Pineda
role: Study Chair
affiliation: Escuela Neijing Colombia
facility: 
facility: 
country: Colombia
citation: Gutierrez L, Pineda S, Gutierrez R, Ferrer L. Acupuncture in Macular Diseases (AMAD) No published yet
responsible party type: Principal Investigator
investigator affiliation: Escuela Neijing
investigator full name: Dra. Luz Helena Gutiérrez C
investigator title: Luz Gutierrez Physician, MPH, Escuela Neijing, Research Coordinator.
mesh term: Macular Degeneration
mesh term: Stargardt Disease
sharing ipd: Yes
ipd description: sex, age, ophthalmologic diagnostic data (medical examination, images) diagnostic signs on Traditional Chinese Medicine (TCM), number of sessions, visual outcome, hazards, previous treatment. Individual participant data that underlie the results reported will be shared after deidentification
ipd info type: Clinical Study Report (CSR)
ipd time frame: Inmediate following publication and no end term.
ipd access criteria: Any
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Participants were limited by lack of knowing and credibility of ophthalmologists in TCM OCTs every 6 months was not possible for some due to the cost. Some patients had independent evaluation and their ophthalmologist appreciated the results.
point of contact: 