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/NCT06023108</url>
    </required_header>
    <id_info>
      <org_study_id>orthokeratology 2023</org_study_id>
      <nct_id>NCT06023108</nct_id>
    </id_info>
    <brief_title>Assess the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.</brief_title>
    <official_title>A Single Center,Randomized,Controlled Trial Assessing the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>He Eye Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>He Eye Hospital</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>
        Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping&#xD;
        the corneal epithelium to change refractive power. Due to its contact with the ocular&#xD;
        surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well&#xD;
        as changes in tear film stability. This prospective study randomly divided 300 children and&#xD;
        adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At&#xD;
        baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface&#xD;
        disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH),&#xD;
        conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration,&#xD;
        and point-of-care Lymphotoxin alpha (LTA) test.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be conducted in compliance with the tenets of the Declaration of Helsinki and&#xD;
        the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China [ethics&#xD;
        approval number:&#xD;
  &#xD;
        In recent years, the prevalence of myopia has significantly increased nationwide, The&#xD;
        incidence rate of myopia among adolescents in China has risen significantly, causing blurred&#xD;
        vision. Severe myopia can cause complications that threaten vision, such as glaucoma and&#xD;
        macula disease. It would be highly undesirable to increase the social burden. Myopia can be&#xD;
        corrected by orthokeratology (OK) and spectacles. It has been shown in numerous researches&#xD;
        that orthokeratology lens are recognized as one of the effective methods in the treatment of&#xD;
        myopia, has been widely used nationwide. In current years, the clinical treatment of myopia&#xD;
        by OK lens in adolescents are increasingly confirmed to prevent the progression. Traditional&#xD;
        OK lenses change refractive power by reshaping the corneal Epithelium (leading to the&#xD;
        redistribution of corneal epithelium). As the overnight OK lens directly contact the ocular&#xD;
        surface, the patients may endure symptoms and signs of dry eye disease (DED), which may even&#xD;
        have some impact on the health of the ocular surface, including potential complications such&#xD;
        as Keratitis. In addition, corneal staining often has occurred in ook wearers. According to&#xD;
        previous studies, it has shown that wearing contact lens will affect the tear film stability,&#xD;
        damage the function of the meibomian gland, tear film thinning, its affect ocular&#xD;
        inflammation. Recent studies have also shown that OK continuous wearing has the least impact&#xD;
        at 12 months. In order to ensure the safety of long-term wearing ok lenses in children and&#xD;
        adolescents, the effect of OK lens on tear film and meibomian gland demonstrated further&#xD;
        exploration.&#xD;
  &#xD;
        The aim of this study is to evaluate the effect of OK on the ocular surface and meibomian&#xD;
        gland function in children and adolescents. To assess the effect of OK on ocular surface and&#xD;
        meibomian gland function in children and adolescents, so as to improve the application of the&#xD;
        clinical.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 23, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Non-invasive tear break-up time</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>OSDI Score</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VAS score</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tear meniscus height (TMH)</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conjunctival hyperemia (RS score)</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Meibomian gland score (meiboscore)</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>Meibomian gland score will be assessed by keratograph image (Oculus, Germany) .The meibomian gland can be scored that ranges from grade 0 (no loss) to grade 3 (more than two third loss).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MMP-9 detection</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LTA</measure>
      <time_frame>Day-0 (baseline), 1-month ,3-month,6-month and 12-month.</time_frame>
      <description>LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Dry Eye Disease</condition>
    <arm_group>
      <arm_group_label>Orthokeratology group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Spectacles group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in spectacles group will wear per day for 12 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Orthokeratology</intervention_name>
      <description>OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.</description>
      <arm_group_label>Orthokeratology group</arm_group_label>
      <other_name>OK lenses</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Spectacles</intervention_name>
      <description>Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.</description>
      <arm_group_label>Spectacles group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (i)myopia up to -5.5D; and with-the-rule astigmatism of up to 1.5 DC or against-the rule&#xD;
          astigmatism of &lt;-0.5DC with keratometry from 40 to 45D ; (ii)participants and guardians&#xD;
          agree to be randomly assigned and are willing to cooperate with doctors for follow-up and&#xD;
          examination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (i) existing ocular trauma, infectious diseases, recent surgical history; (ii) keratitis or&#xD;
          any ocular inflammation or infection; recently wearing contact lenses; allergy history;&#xD;
          (iii) glaucoma, active uveitis or retinal disease; (iv) systemic diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emmanuel Eric E Pazo, PHD</last_name>
      <role>Study Chair</role>
      <affiliation>He Eye Hospital, Shenyang, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emmanuel Eric E Pazo, PHD</last_name>
      <phone>0086-18612782131</phone>
      <email>ericpazo@outlook.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yilin Song, MD</last_name>
      <phone>0086-18842649801</phone>
      <email>songyilin1432@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>He Eye Hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110001</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yilin Song, MD</last_name>
        <phone>0086-18842649801</phone>
        <email>songyilin1432@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Emmanuel Eric Pazo, PHD</last_name>
        <phone>0086-18612782131</phone>
        <email>ericpazo@outlook.com</email>
      </contact_backup>
      <investigator>
        <last_name>Jiyan Chen, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Tao Z, Wang J, Zhu M, Lin Z, Zhao J, Tang Y, Deng H. Does Orthokeratology Wearing Affect the Tear Quality of Children? Front Pediatr. 2022 Jan 18;9:773484. doi: 10.3389/fped.2021.773484. eCollection 2021.</citation>
      <PMID>35118029</PMID>
    </results_reference>
    <results_reference>
      <citation>Hui W, Xiao-Feng H, Song-Guo L, Jing-Jing W, Xuan H, Yong T. Application of orthokeratology on myopia control and its effect on ocular surface and meibomian gland function in Chinese myopic adolescents. Front Med (Lausanne). 2022 Dec 8;9:979334. doi: 10.3389/fmed.2022.979334. eCollection 2022.</citation>
      <PMID>36569150</PMID>
    </results_reference>
    <results_reference>
      <citation>Yan ZP. Dry eye symptoms and signs in children wearing OK lenses for six months in China. J Fr Ophtalmol. 2020 Mar;43(3):211-215. doi: 10.1016/j.jfo.2019.07.029. Epub 2020 Jan 27.</citation>
      <PMID>32000988</PMID>
    </results_reference>
    <results_reference>
      <citation>Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.</citation>
      <PMID>23109740</PMID>
    </results_reference>
    <results_reference>
      <citation>Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.</citation>
      <PMID>21212181</PMID>
    </results_reference>
    <results_reference>
      <citation>He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.</citation>
      <PMID>27464993</PMID>
    </results_reference>
    <results_reference>
      <citation>Nti AN, Berntsen DA. Optical changes and visual performance with orthokeratology. Clin Exp Optom. 2020 Jan;103(1):44-54. doi: 10.1111/cxo.12947. Epub 2019 Aug 4.</citation>
      <PMID>31378996</PMID>
    </results_reference>
    <results_reference>
      <citation>Wang X, Li J, Zhang R, Li N, Pang Y, Zhang Y, Wei R. The Influence of Overnight Orthokeratology on Ocular Surface and Meibomian Gland Dysfunction in Teenagers with Myopia. J Ophthalmol. 2019 Jan 21;2019:5142628. doi: 10.1155/2019/5142628. eCollection 2019.</citation>
      <PMID>30805209</PMID>
    </results_reference>
    <results_reference>
      <citation>Yang L, Zhang L, Jian Hu R, Yu PP, Jin X. The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A, IL-6, and PGE2 in children. Cont Lens Anterior Eye. 2021 Feb;44(1):81-88. doi: 10.1016/j.clae.2020.04.001. Epub 2020 Apr 30.</citation>
      <PMID>32359968</PMID>
    </results_reference>
    <results_reference>
      <citation>Yu H, Yuan Y, Wu W, Zeng W, Tong L, Zhang Y, Feng Y. Orthokeratology Lens Wear for 2 Years in Children Did Not Alter Tear Film Lipid Thickness by Non-Invasive Interferometry. Front Med (Lausanne). 2022 Feb 10;9:821106. doi: 10.3389/fmed.2022.821106. eCollection 2022.</citation>
      <PMID>35223920</PMID>
    </results_reference>
    <results_reference>
      <citation>Lee J, Hwang G, Ha M, Kim HS, Han K, Na KS. Evaluation of the meibomian glands using the tear interferometer wearing orthokeratology lenses. BMC Ophthalmol. 2022 Mar 24;22(1):133. doi: 10.1186/s12886-022-02365-3.</citation>
      <PMID>35331178</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Myopia</keyword>
    <keyword>Orthokeratology</keyword>
    <keyword>Tear film</keyword>
    <keyword>Dry eye</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
      <mesh_term>Eye Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high-impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT06023108
  org study id: orthokeratology 2023
  nct id: NCT06023108
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping
        the corneal epithelium to change refractive power. Due to its contact with the ocular
        surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well
        as changes in tear film stability. This prospective study randomly divided 300 children and
        adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At
        baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface
        disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH),
        conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration,
        and point-of-care Lymphotoxin alpha (LTA) test.
  This study will be conducted in compliance with the tenets of the Declaration of Helsinki and
        the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China [ethics
        approval number:
  
        In recent years, the prevalence of myopia has significantly increased nationwide, The
        incidence rate of myopia among adolescents in China has risen significantly, causing blurred
        vision. Severe myopia can cause complications that threaten vision, such as glaucoma and
        macula disease. It would be highly undesirable to increase the social burden. Myopia can be
        corrected by orthokeratology (OK) and spectacles. It has been shown in numerous researches
        that orthokeratology lens are recognized as one of the effective methods in the treatment of
        myopia, has been widely used nationwide. In current years, the clinical treatment of myopia
        by OK lens in adolescents are increasingly confirmed to prevent the progression. Traditional
        OK lenses change refractive power by reshaping the corneal Epithelium (leading to the
        redistribution of corneal epithelium). As the overnight OK lens directly contact the ocular
        surface, the patients may endure symptoms and signs of dry eye disease (DED), which may even
        have some impact on the health of the ocular surface, including potential complications such
        as Keratitis. In addition, corneal staining often has occurred in ook wearers. According to
        previous studies, it has shown that wearing contact lens will affect the tear film stability,
        damage the function of the meibomian gland, tear film thinning, its affect ocular
        inflammation. Recent studies have also shown that OK continuous wearing has the least impact
        at 12 months. In order to ensure the safety of long-term wearing ok lenses in children and
        adolescents, the effect of OK lens on tear film and meibomian gland demonstrated further
        exploration.
  
        The aim of this study is to evaluate the effect of OK on the ocular surface and meibomian
        gland function in children and adolescents. To assess the effect of OK on ocular surface and
        meibomian gland function in children and adolescents, so as to improve the application of the
        clinical.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Non-invasive tear break-up time
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
  measure: OSDI Score
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points.
  measure: VAS score
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100).
  measure: Tear meniscus height (TMH)
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer
  measure: Conjunctival hyperemia (RS score)
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.
  measure: Meibomian gland score (meiboscore)
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: Meibomian gland score will be assessed by keratograph image (Oculus, Germany) .The meibomian gland can be scored that ranges from grade 0 (no loss) to grade 3 (more than two third loss).
  measure: MMP-9 detection
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology.
  measure: LTA
  time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
  description: LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.
  arm group label: Orthokeratology group
  arm group type: Experimental
  description: Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months.
  arm group label: Spectacles group
  arm group type: Active Comparator
  description: Participants in spectacles group will wear per day for 12 months.
  intervention type: Device
  intervention name: Orthokeratology
  description: OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.
  arm group label: Orthokeratology group
  other name: OK lenses
  intervention type: Device
  intervention name: Spectacles
  description: Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.
  arm group label: Spectacles group
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Emmanuel Eric E Pazo, PHD
  role: Study Chair
  affiliation: He Eye Hospital, Shenyang, China
  last name: Emmanuel Eric E Pazo, PHD
  phone: 0086-18612782131
  email: ericpazo@outlook.com
  last name: Yilin Song, MD
  phone: 0086-18842649801
  email: songyilin1432@163.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Tao Z, Wang J, Zhu M, Lin Z, Zhao J, Tang Y, Deng H. Does Orthokeratology Wearing Affect the Tear Quality of Children? Front Pediatr. 2022 Jan 18;9:773484. doi: 10.3389/fped.2021.773484. eCollection 2021.
  PMID: 35118029
  citation: Hui W, Xiao-Feng H, Song-Guo L, Jing-Jing W, Xuan H, Yong T. Application of orthokeratology on myopia control and its effect on ocular surface and meibomian gland function in Chinese myopic adolescents. Front Med (Lausanne). 2022 Dec 8;9:979334. doi: 10.3389/fmed.2022.979334. eCollection 2022.
  PMID: 36569150
  citation: Yan ZP. Dry eye symptoms and signs in children wearing OK lenses for six months in China. J Fr Ophtalmol. 2020 Mar;43(3):211-215. doi: 10.1016/j.jfo.2019.07.029. Epub 2020 Jan 27.
  PMID: 32000988
  citation: Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.
  PMID: 23109740
  citation: Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
  PMID: 21212181
  citation: He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.
  PMID: 27464993
  citation: Nti AN, Berntsen DA. Optical changes and visual performance with orthokeratology. Clin Exp Optom. 2020 Jan;103(1):44-54. doi: 10.1111/cxo.12947. Epub 2019 Aug 4.
  PMID: 31378996
  citation: Wang X, Li J, Zhang R, Li N, Pang Y, Zhang Y, Wei R. The Influence of Overnight Orthokeratology on Ocular Surface and Meibomian Gland Dysfunction in Teenagers with Myopia. J Ophthalmol. 2019 Jan 21;2019:5142628. doi: 10.1155/2019/5142628. eCollection 2019.
  PMID: 30805209
  citation: Yang L, Zhang L, Jian Hu R, Yu PP, Jin X. The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A, IL-6, and PGE2 in children. Cont Lens Anterior Eye. 2021 Feb;44(1):81-88. doi: 10.1016/j.clae.2020.04.001. Epub 2020 Apr 30.
  PMID: 32359968
  citation: Yu H, Yuan Y, Wu W, Zeng W, Tong L, Zhang Y, Feng Y. Orthokeratology Lens Wear for 2 Years in Children Did Not Alter Tear Film Lipid Thickness by Non-Invasive Interferometry. Front Med (Lausanne). 2022 Feb 10;9:821106. doi: 10.3389/fmed.2022.821106. eCollection 2022.
  PMID: 35223920
  citation: Lee J, Hwang G, Ha M, Kim HS, Han K, Na KS. Evaluation of the meibomian glands using the tear interferometer wearing orthokeratology lenses. BMC Ophthalmol. 2022 Mar 24;22(1):133. doi: 10.1186/s12886-022-02365-3.
  PMID: 35331178
  responsible party type: Sponsor
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  mesh term: Eye Diseases
  sharing ipd: Yes
  ipd description: The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high-impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.
  ipd info type: Study Protocol