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/NCT05999552</url>
    </required_header>
    <id_info>
      <org_study_id>Eye Exercises</org_study_id>
      <nct_id>NCT05999552</nct_id>
    </id_info>
    <brief_title>The Effect of Eye Exercises in Individuals With Eye Refractive Defects</brief_title>
    <official_title>The Effect of Eye Exercises Applied on Individuals With Eye Refractive Defects on Visual Function and Quality of Life</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Halic University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bahçeşehir University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yuzuncu Yıl University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hacettepe University</source>
    <oversight_info>
      <has_dmc>No</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>
        According to the World Health Organization's statement published in 2014, 43% of visual&#xD;
        impairment is overhauled by uncorrected refractive errors. The change of body and angle of&#xD;
        light waves while undergoing changes in the environment due to the temperature difference&#xD;
        between the environments is called refraction. The refractive errors found in the eye can be&#xD;
        discovered as myopia, astigmatism, hyperopia, and presbyopia. As there are different&#xD;
        prevalence methods in eye refractive errors in various publications. According to many&#xD;
        studies in the literature, eye exercises in many conditions such as convergence collapse,&#xD;
        accommodation dysfunction, movement center of the eye, digital eye strain and dry eye are&#xD;
        curative and therapeutic without any control. With eye exercises, blood is applied to the&#xD;
        ocular region, the humor is stimulated, the tension of the extraocular muscles is reduced,&#xD;
        the coordination between the eye muscles is increased, the eye fatigue and stress are&#xD;
        reduced. Depending on the effects of these effects, positive changes are seen on vision&#xD;
        tests. Although there is a different view in the literature that includes these eye exercises&#xD;
        and their benefits, it has been found to be insufficient in current studies. More work needs&#xD;
        to be done in this area so that these results can be stated better and more clearly. With&#xD;
        this study, investigators aim to shed light on what can be done in this field by filling&#xD;
        these residents in the literature and to examine the visual function and quality of life of&#xD;
        eye exercises.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nottingham Health profile</measure>
      <time_frame>baseline, after 8 weeks</time_frame>
      <description>This questionnaire assesses the perception of health-related quality of life. The total score is between 0-600. A high score is an indication of a bad outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>National Institute of Ophthalmology Visual Function Scale</measure>
      <time_frame>baseline, after 8 weeks</time_frame>
      <description>Used to measure vision-related quality of life in patients with chronic eye disease. Overall scores ranged from 0 to 100, with higher scores indicating better quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Standardized Mini-Mental Test</measure>
      <time_frame>baseline</time_frame>
      <description>It is a scale that determines the cognitive level of the participants. It consists of eleven questions and is evaluated over 30 points. 24-30 points are normal, 18-23 points mild dementia, 10-17 points dementia, 10 points and below are compatible with severe dementia.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Individuals With Eye Refraction Defects</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>any exercise program will not be applied and will only be followed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>eye exercise program will be applied.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Eye exercises</intervention_name>
      <description>The treatment will be applied in three sessions a week for eight weeks and each session will be approximately 20 minutes. Individuals will do each exercise shown at home as a home program on other days (days when the physiotherapist does not perform the exercise by video call).</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          be between the ages of 18-65, Having any refractive or visual impairment (myopia,&#xD;
          hyperopia, astigmatism) by an ophthalmologist, not have other eye problems in addition to&#xD;
          these vision defects, to score at least 24 on the Standardized Mini Mental Test.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          having undergone any eye surgery (including laser operations), have a prosthetic eye have&#xD;
          congenital vision loss, have any disease that will affect the eyesight. Individuals meeting&#xD;
          these criteria will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Emine Nur Demircan, PT, MSc</last_name>
      <phone>+905363978568</phone>
      <email>fztendmrcn@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Blindness and visual impairment. [Internet]. World Health Organization, 2014.</citation>
    </reference>
    <reference>
      <citation>Convergence Insufficiency Treatment Trial (CITT) Study Group. The convergence insufficiency treatment trial: design, methods, and baseline data. Ophthalmic Epidemiol. 2008 Jan-Feb;15(1):24-36. doi: 10.1080/09286580701772037.</citation>
      <PMID>18300086</PMID>
    </reference>
    <reference>
      <citation>Horwood A, Toor S. Clinical test responses to different orthoptic exercise regimes in typical young adults. Ophthalmic Physiol Opt. 2014 Mar;34(2):250-62. doi: 10.1111/opo.12109. Epub 2014 Jan 29.</citation>
      <PMID>24471739</PMID>
    </reference>
    <reference>
      <citation>Cacho Martinez P, Garcia Munoz A, Ruiz-Cantero MT. Treatment of accommodative and nonstrabismic binocular dysfunctions: a systematic review. Optometry. 2009 Dec;80(12):702-16. doi: 10.1016/j.optm.2009.06.011.</citation>
      <PMID>19932444</PMID>
    </reference>
    <reference>
      <citation>Minoonejad H, Barati AH, Naderifar H, Heidari B, Kazemi AS, Lashay A. Effect of four weeks of ocular-motor exercises on dynamic visual acuity and stability limit of female basketball players. Gait Posture. 2019 Sep;73:286-290. doi: 10.1016/j.gaitpost.2019.06.022. Epub 2019 Jul 16.</citation>
      <PMID>31398634</PMID>
    </reference>
    <reference>
      <citation>Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.</citation>
      <PMID>21334899</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Emine Nur Demircan</investigator_full_name>
      <investigator_title>Senior Physiotherapist</investigator_title>
    </responsible_party>
    <keyword>Ocular Refraction</keyword>
    <keyword>Eye</keyword>
    <keyword>Exercise</keyword>
    <keyword>Life Quality</keyword>
    <keyword>Ocular vision</keyword>
    <patient_data>
      <sharing_ipd>Yes</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/NCT05999552
  org study id: Eye Exercises
  nct id: NCT05999552
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  According to the World Health Organization's statement published in 2014, 43% of visual
        impairment is overhauled by uncorrected refractive errors. The change of body and angle of
        light waves while undergoing changes in the environment due to the temperature difference
        between the environments is called refraction. The refractive errors found in the eye can be
        discovered as myopia, astigmatism, hyperopia, and presbyopia. As there are different
        prevalence methods in eye refractive errors in various publications. According to many
        studies in the literature, eye exercises in many conditions such as convergence collapse,
        accommodation dysfunction, movement center of the eye, digital eye strain and dry eye are
        curative and therapeutic without any control. With eye exercises, blood is applied to the
        ocular region, the humor is stimulated, the tension of the extraocular muscles is reduced,
        the coordination between the eye muscles is increased, the eye fatigue and stress are
        reduced. Depending on the effects of these effects, positive changes are seen on vision
        tests. Although there is a different view in the literature that includes these eye exercises
        and their benefits, it has been found to be insufficient in current studies. More work needs
        to be done in this area so that these results can be stated better and more clearly. With
        this study, investigators aim to shed light on what can be done in this field by filling
        these residents in the literature and to examine the visual function and quality of life of
        eye exercises.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Nottingham Health profile
  time frame: baseline, after 8 weeks
  description: This questionnaire assesses the perception of health-related quality of life. The total score is between 0-600. A high score is an indication of a bad outcome.
  measure: National Institute of Ophthalmology Visual Function Scale
  time frame: baseline, after 8 weeks
  description: Used to measure vision-related quality of life in patients with chronic eye disease. Overall scores ranged from 0 to 100, with higher scores indicating better quality of life.
  measure: Standardized Mini-Mental Test
  time frame: baseline
  description: It is a scale that determines the cognitive level of the participants. It consists of eleven questions and is evaluated over 30 points. 24-30 points are normal, 18-23 points mild dementia, 10-17 points dementia, 10 points and below are compatible with severe dementia.
  arm group label: Control Group
  arm group type: No Intervention
  description: any exercise program will not be applied and will only be followed.
  arm group label: Experimental Group
  arm group type: Experimental
  description: eye exercise program will be applied.
  intervention type: Other
  intervention name: Eye exercises
  description: The treatment will be applied in three sessions a week for eight weeks and each session will be approximately 20 minutes. Individuals will do each exercise shown at home as a home program on other days (days when the physiotherapist does not perform the exercise by video call).
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emine Nur Demircan, PT, MSc
  phone: +905363978568
  email: fztendmrcn@gmail.com
  citation: Blindness and visual impairment. [Internet]. World Health Organization, 2014.
  citation: Convergence Insufficiency Treatment Trial (CITT) Study Group. The convergence insufficiency treatment trial: design, methods, and baseline data. Ophthalmic Epidemiol. 2008 Jan-Feb;15(1):24-36. doi: 10.1080/09286580701772037.
  PMID: 18300086
  citation: Horwood A, Toor S. Clinical test responses to different orthoptic exercise regimes in typical young adults. Ophthalmic Physiol Opt. 2014 Mar;34(2):250-62. doi: 10.1111/opo.12109. Epub 2014 Jan 29.
  PMID: 24471739
  citation: Cacho Martinez P, Garcia Munoz A, Ruiz-Cantero MT. Treatment of accommodative and nonstrabismic binocular dysfunctions: a systematic review. Optometry. 2009 Dec;80(12):702-16. doi: 10.1016/j.optm.2009.06.011.
  PMID: 19932444
  citation: Minoonejad H, Barati AH, Naderifar H, Heidari B, Kazemi AS, Lashay A. Effect of four weeks of ocular-motor exercises on dynamic visual acuity and stability limit of female basketball players. Gait Posture. 2019 Sep;73:286-290. doi: 10.1016/j.gaitpost.2019.06.022. Epub 2019 Jul 16.
  PMID: 31398634
  citation: Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.
  PMID: 21334899
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Emine Nur Demircan
  investigator title: Senior Physiotherapist
  sharing ipd: Yes