xml: <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/NCT06034912</url>
    </required_header>
    <id_info>
      <org_study_id>RLRL RCT</org_study_id>
      <nct_id>NCT06034912</nct_id>
    </id_info>
    <brief_title>RCT on Red Light Treatment for Myopic Minors' Retinal Impact</brief_title>
    <official_title>Randomized Controlled Study on the Effects of Repetitive Low-Intensity Red Light Therapy on the Retina of Minors With Myopia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. Research Objective: The primary objective is to investigate the short-term effects of&#xD;
             repetitive low-intensity red light therapy on the fundus of the eyes of underage&#xD;
             individuals with myopia.&#xD;
  &#xD;
          2. Research Design: This experiment employs a prospective, single-center, randomized,&#xD;
             controlled clinical research design.&#xD;
  &#xD;
          3. Primary Outcome: Changes in macular sensitivity (microperimetry).&#xD;
  &#xD;
          4. Recruitment and Participant Information: The study population consists of individuals&#xD;
             aged 7 to 17 years old. It is anticipated that there will be 35 participants in both the&#xD;
             control group and the experimental group.&#xD;
  &#xD;
          5. Trial Location: Zhongshan Ophthalmic Center, Sun Yat-sen University. Contact&#xD;
             Information: Shuyu Chen, +190805155537, chenshuyu980916@163.com.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Research Design: This study is an observational research aimed at investigating the&#xD;
             short-term effects of repeated low-intensity red light therapy on the fundus of underage&#xD;
             individuals with myopia. Retinal light damage typically occurs in the photoreceptor&#xD;
             layer and retinal pigment epithelium. Optical coherence tomography angiography (OCTA),&#xD;
             OCT, pattern visual evoked potentials (VEP), microperimetry, and multifocal&#xD;
             electroretinography (ERG) will be utilized to assess the functionality of the retina,&#xD;
             choroid, and optic nerve, thus identifying potential areas of damage. This will provide&#xD;
             a scientific basis for further evaluating the safety of low-intensity red light therapy.&#xD;
  &#xD;
          2. Participant Recruitment:&#xD;
  &#xD;
        (1) Age range: 7 to 17 years old. (2) Spherical equivalent refraction (SER): -1.00 to -5.00D.&#xD;
        (3) Astigmatism: ≤ 2.50D. (4) Refractive anisometry (difference between the two equivalent&#xD;
        spherical lenses): ≤ 1.50D.&#xD;
  &#xD;
        (5) Best corrected visual acuity (BCVA) in either eye: ≥ 20/20. (6) Willingness to undergo&#xD;
        low-intensity red light treatment. (7) Ability to comprehend the trial's purpose, voluntary&#xD;
        participation, and signing of an informed consent form by the subject and their legal&#xD;
        guardian.&#xD;
  &#xD;
        3.Intervention:Control Group: Daily wear of frame glasses for refractive correction, without&#xD;
        any additional treatment for myopia control.Experimental Group: Daily wear of frame glasses&#xD;
        for refractive correction, along with low-intensity red light therapy as prescribed by the&#xD;
        optometrist.&#xD;
  &#xD;
        4.Data Collection: All examinations are conducted by experienced doctors，technicians, and&#xD;
        optometrists during objective assessments. Data collection forms are incorporated into the&#xD;
        medical records. Specialized research coordinators conduct regular follow-up with all&#xD;
        subjects via telephone or WeChat.&#xD;
  &#xD;
        5.Ethical Review: The trial protocol was developed before the clinical trial commenced and&#xD;
        received approval from the ethics committee.&#xD;
  &#xD;
        6.Results and Analysis: Data statistical analysis will be performed using SPSS 26.0&#xD;
        statistical software. The Kolmogorov-Smirnov test will be employed for normality distribution&#xD;
        testing. Variables following a normal distribution will be expressed as mean ± standard&#xD;
        deviation (Mean±SD). Between-group comparisons will be conducted using one-way analysis of&#xD;
        variance. Paired t-tests will be used for pre- and post-red light exposure data. Non-normally&#xD;
        distributed data will be expressed as median (interquartile range) [M(Q)] and analyzed using&#xD;
        rank-sum tests. A significance level of P &lt; 0.05 will indicate statistically significant&#xD;
        differences.&#xD;
  &#xD;
        7.Safety and Side Effects: None. 8.Discussion and Conclusion: None.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 28, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 29, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in visual acuity in the macula (micro-visual field)</measure>
      <time_frame>1 day、1 month、3 months、6 monthes after treatment</time_frame>
      <description>All participants were treated with a microvisual field meter for fundus imaging and microvisual field examination without mydriasis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amplitude and latency of P100 waves</measure>
      <time_frame>1 day、1 month、3 months、6 monthes after treatment</time_frame>
      <description>Pattern visual evoked potentials (P-VEP) were used to detect the functional integrity of the visual pathway, and the amplitude and latency of the P100 wave were recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Choroidal thickness</measure>
      <time_frame>1 day、1 month、3 months、6 monthes after treatment</time_frame>
      <description>Optical coherence tomography (OCT) was used for choroidal thickness measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amplitude and latency of P1 waves</measure>
      <time_frame>1 day、1 month、3 months、6 monthes after treatment</time_frame>
      <description>Multifocal electroretinaogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the amplitude of P1 wave (expressed by reaction density) and latency were recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Choroidal and retinal blood flow density assessment</measure>
      <time_frame>1 day、1 month、3 months、6 monthes after treatment</time_frame>
      <description>Optical coherence tomography angiography (OCTA) was used to scan the choroidal and retinal scans of both eyes to check the blood flow density of the choroidal capillary layer, superficial retinal capillary layer, middle retinal capillary layer and deep retinal capillary layer.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <description>Intervention method：Wearing frame glasses daily + low-intensity red light irradiation for myopia treatment.&#xD;
  Planned visits and durations： Follow-up visits will be conducted with patients before red light irradiation, on the first day after two sessions of red light irradiation, before red light irradiation on the second day, one month later, three months later, and six months later.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>Intervention method:：Wearing frame glasses daily&#xD;
  Planned visits and durations：After participating in the study, follow-up will be conducted six months later.&quot;</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          1. Population Characteristics: Ages 7 to 17 years old.&#xD;
  &#xD;
            2. Disease Characteristics: Myopia patients.&#xD;
  &#xD;
            3. Recruitment Method: The researcher assesses the eligibility of each patient for&#xD;
               inclusion in the study, and if the criteria are met, extends an invitation to&#xD;
               participate in the research.&#xD;
  &#xD;
            4. Number and Sample Size: 35 participants will be enrolled in each group, for a total of&#xD;
               70 participants.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 7~17 years old；&#xD;
  &#xD;
            2. Spherical equivalent refraction (SER) -1.00 to -5.00D；&#xD;
  &#xD;
            3. Astigmatism≤ 2.50D；&#xD;
  &#xD;
            4. Refractive anisometry (difference between the two equivalent spherical lenses) ≤&#xD;
               1.50D；&#xD;
  &#xD;
            5. Best corrected visual acuity (BCVA) in either eye ≥ 20/20；&#xD;
  &#xD;
            6. Currently willing to use low-intensity red light treatment；&#xD;
  &#xD;
            7. Be able to understand the purpose of the trial, voluntarily participate and have the&#xD;
               subject and his legal guardian sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. strabismus (apparent strabismus) or amblyopia；&#xD;
  &#xD;
            2. Correction of abnormal vision in either eye；&#xD;
  &#xD;
            3. Any eye disease that may be related to myopia or affect refractive development, such&#xD;
               as history of photosensitivity, macular disease, moderate to severe dry eye, corneal&#xD;
               disease, cataract, vitreoretinal disease, infectious conjunctivitis, uveitis,&#xD;
               opticnerve damage, congenital optic nerve development abnormalities or other eye&#xD;
               diseases；&#xD;
  &#xD;
            4. Systemic diseases, such as hypertension, lupus erythematosus, albinism, diabetes, etc；&#xD;
  &#xD;
            5. previous history of convulsions, tics, central nervous system underdevelopment,&#xD;
               psoriasis, epilepsy and psychiatric and psychological diseases；&#xD;
  &#xD;
            6. used within 3 months or planned to use low-concentration atropine eye drops during the&#xD;
               study；&#xD;
  &#xD;
            7. Those who have previously used orthokeratology lenses, peripheral defocusing glasses,&#xD;
               multifocal soft lenses and other optical therapies to control the progression of&#xD;
               myopia, and the elution period is less than three months；&#xD;
  &#xD;
            8. Other situations in which the investigator believes that the patient is not suitable&#xD;
               to participate in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ma Jin, professor</last_name>
      <role>Study Chair</role>
      <affiliation>Professor at Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chen Shuyu</last_name>
      <phone>+190805155537</phone>
      <email>chenshuyu980916@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus)</name>
        <address>
          <city>Guangzhou</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chen Shuyu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Jin Ma</investigator_full_name>
      <investigator_title>Professor at Sun Yat-sen University, Chief Physician at Sun Yat-sen University Hospital, and Doctoral Supervisor at Sun Yat-sen University.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Retinal Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034912
  org study id: RLRL RCT
  nct id: NCT06034912
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. Research Objective: The primary objective is to investigate the short-term effects of
             repetitive low-intensity red light therapy on the fundus of the eyes of underage
             individuals with myopia.
  
          2. Research Design: This experiment employs a prospective, single-center, randomized,
             controlled clinical research design.
  
          3. Primary Outcome: Changes in macular sensitivity (microperimetry).
  
          4. Recruitment and Participant Information: The study population consists of individuals
             aged 7 to 17 years old. It is anticipated that there will be 35 participants in both the
             control group and the experimental group.
  
          5. Trial Location: Zhongshan Ophthalmic Center, Sun Yat-sen University. Contact
             Information: Shuyu Chen, +190805155537, chenshuyu980916@163.com.
  1. Research Design: This study is an observational research aimed at investigating the
             short-term effects of repeated low-intensity red light therapy on the fundus of underage
             individuals with myopia. Retinal light damage typically occurs in the photoreceptor
             layer and retinal pigment epithelium. Optical coherence tomography angiography (OCTA),
             OCT, pattern visual evoked potentials (VEP), microperimetry, and multifocal
             electroretinography (ERG) will be utilized to assess the functionality of the retina,
             choroid, and optic nerve, thus identifying potential areas of damage. This will provide
             a scientific basis for further evaluating the safety of low-intensity red light therapy.
  
          2. Participant Recruitment:
  
        (1) Age range: 7 to 17 years old. (2) Spherical equivalent refraction (SER): -1.00 to -5.00D.
        (3) Astigmatism: ≤ 2.50D. (4) Refractive anisometry (difference between the two equivalent
        spherical lenses): ≤ 1.50D.
  
        (5) Best corrected visual acuity (BCVA) in either eye: ≥ 20/20. (6) Willingness to undergo
        low-intensity red light treatment. (7) Ability to comprehend the trial's purpose, voluntary
        participation, and signing of an informed consent form by the subject and their legal
        guardian.
  
        3.Intervention:Control Group: Daily wear of frame glasses for refractive correction, without
        any additional treatment for myopia control.Experimental Group: Daily wear of frame glasses
        for refractive correction, along with low-intensity red light therapy as prescribed by the
        optometrist.
  
        4.Data Collection: All examinations are conducted by experienced doctors，technicians, and
        optometrists during objective assessments. Data collection forms are incorporated into the
        medical records. Specialized research coordinators conduct regular follow-up with all
        subjects via telephone or WeChat.
  
        5.Ethical Review: The trial protocol was developed before the clinical trial commenced and
        received approval from the ethics committee.
  
        6.Results and Analysis: Data statistical analysis will be performed using SPSS 26.0
        statistical software. The Kolmogorov-Smirnov test will be employed for normality distribution
        testing. Variables following a normal distribution will be expressed as mean ± standard
        deviation (Mean±SD). Between-group comparisons will be conducted using one-way analysis of
        variance. Paired t-tests will be used for pre- and post-red light exposure data. Non-normally
        distributed data will be expressed as median (interquartile range) [M(Q)] and analyzed using
        rank-sum tests. A significance level of P < 0.05 will indicate statistically significant
        differences.
  
        7.Safety and Side Effects: None. 8.Discussion and Conclusion: None.
  observational model: Case-Control
  time perspective: Prospective
  measure: Changes in visual acuity in the macula (micro-visual field)
  time frame: 1 day、1 month、3 months、6 monthes after treatment
  description: All participants were treated with a microvisual field meter for fundus imaging and microvisual field examination without mydriasis.
  measure: Amplitude and latency of P100 waves
  time frame: 1 day、1 month、3 months、6 monthes after treatment
  description: Pattern visual evoked potentials (P-VEP) were used to detect the functional integrity of the visual pathway, and the amplitude and latency of the P100 wave were recorded.
  measure: Choroidal thickness
  time frame: 1 day、1 month、3 months、6 monthes after treatment
  description: Optical coherence tomography (OCT) was used for choroidal thickness measurement.
  measure: Amplitude and latency of P1 waves
  time frame: 1 day、1 month、3 months、6 monthes after treatment
  description: Multifocal electroretinaogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the amplitude of P1 wave (expressed by reaction density) and latency were recorded.
  measure: Choroidal and retinal blood flow density assessment
  time frame: 1 day、1 month、3 months、6 monthes after treatment
  description: Optical coherence tomography angiography (OCTA) was used to scan the choroidal and retinal scans of both eyes to check the blood flow density of the choroidal capillary layer, superficial retinal capillary layer, middle retinal capillary layer and deep retinal capillary layer.
  arm group label: experimental group
  description: Intervention method：Wearing frame glasses daily + low-intensity red light irradiation for myopia treatment.
  Planned visits and durations： Follow-up visits will be conducted with patients before red light irradiation, on the first day after two sessions of red light irradiation, before red light irradiation on the second day, one month later, three months later, and six months later.
  arm group label: control group
  description: Intervention method:：Wearing frame glasses daily
  Planned visits and durations：After participating in the study, follow-up will be conducted six months later."
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Ma Jin, professor
  role: Study Chair
  affiliation: Professor at Sun Yat-sen University
  last name: Chen Shuyu
  phone: +190805155537
  email: chenshuyu980916@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
  investigator full name: Jin Ma
  investigator title: Professor at Sun Yat-sen University, Chief Physician at Sun Yat-sen University Hospital, and Doctoral Supervisor at Sun Yat-sen University.
  mesh term: Retinal Diseases
  sharing ipd: No