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/NCT06034366</url>
    </required_header>
    <id_info>
      <org_study_id>atropine2023</org_study_id>
      <nct_id>NCT06034366</nct_id>
    </id_info>
    <brief_title>the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression</brief_title>
    <official_title>a Parallel Assignment Prospective, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression</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>
        Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM)&#xD;
        development and progression. Atropine eye drop is beneficial in reducing initial NITM and&#xD;
        slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive&#xD;
        0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM,&#xD;
        cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular&#xD;
        pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week,&#xD;
        36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each&#xD;
        follow-up visit. Adverse events also will be monitored and documented at each subsequent&#xD;
        follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of&#xD;
        NITM and its possible association with the progression of refractive change in Chinese myopic&#xD;
        children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Myopia is a common condition that develops primarily during childhood and early adulthood&#xD;
        when excessive elongation of the eye results in images of distant objects coming into focus&#xD;
        in front of the retina, resulting in blurred distance vision. Myopia is the most common&#xD;
        ocular disorder worldwide, with increasing prevalence over the past decades, predominantly in&#xD;
        East Asia. Previous studies suggested that environmental factors, such as near-work demands,&#xD;
        likely play an important role in myopia development in the younger population.&#xD;
  &#xD;
        Near work, a main environmental-based factor in the development and progression of permanent&#xD;
        myopia (PM), induced via near work-induced transient myopia (NITM). Compared with PM, NITM&#xD;
        refers to the prolonged period required for the accommodation of the eyes to return to a&#xD;
        normal level after engaging in a sustained near task. It was proposed some years ago that&#xD;
        NITM, which produces minor and chronic retinal defocus, may be one of many possible&#xD;
        environmentally-based, myopigenic, contributory factors to permanent myopia.&#xD;
  &#xD;
        As a nonselective muscarinic antagonist, atropine eye drops with different concentrations&#xD;
        have been reported to slow down the myopic progression in myopes. Recently, a two weeks study&#xD;
        assessed the efficacy of a low-concentration of atropine (0.01%) on the initial NITM&#xD;
        magnitude among Chinese myopic children. The results suggested 0.01% atropine reduced the&#xD;
        initial NITM magnitude. However, the long-term efficacy of 0.01% atropine in treating NITM&#xD;
        and the relationship between NITM and refractive change after treatment is still unclear.&#xD;
  &#xD;
        This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its&#xD;
        possible association with the progression of refractive change in Chinese myopic children.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2025</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 (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nearwork-induced transient myopia (NITM) in diopter</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>WAM-5500; Grand Seiko, Japan, will be used to assess the NITM in diopter unit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Spherical equivalent (SE) in diopter</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>WAM-5500; Grand Seiko, Japan, will be used to assess the SE of each eye in diopter unit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Axial length (AL) in millimetre</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>Zeiss IOL Master 700 will be used to assess the AL of each eye in diopter unit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>The NEI-VFQ-25 contains 25 questions: general health, general vision, ocular pain, distance, near tasks, dependency on others, role limitation, mental health, social function, driving, peripheral vision, and color vision difficulty. The answer is converted into a 100-point scale for each question, with 100 being the best and 0 the worst. One or more questions are specific to each subscale; therefore, the subscale score is the average of one or more specific questions. The Chinese version of the NEI-VFQ-25 questionnaire was used</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Safety evaluation of best corrected visual acuity (BCVA)</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) chart will be used to assess BCVA of each eye.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety evaluation of pupil size</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>Pupil size in millimetres will be measured using OPD-Scan III, Nidek, Japan.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety evaluation of intraocular pressure</measure>
      <time_frame>At baseline, week 4, week 12, week 24, week 36, and week 48</time_frame>
      <description>Intraocular pressure (IOP) in mmHg using a tonometry.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Myopia</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the study group will use 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo eye drops</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>participants in the control group will utilize placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.01% atropine</intervention_name>
      <description>0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>0.9% sodium chloride</intervention_name>
      <description>placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks</description>
      <arm_group_label>placebo eye drops</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 6 to 12 years&#xD;
  &#xD;
            -  Subjects and their guardians agreed to participate in this study&#xD;
  &#xD;
            -  Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or&#xD;
               better.&#xD;
  &#xD;
            -  Initial NITM (spherical equivalent) ≤ -0.25 D&#xD;
  &#xD;
            -  Myopic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with systemic diseases or ocular diseases.&#xD;
  &#xD;
            -  previous experiences with myopia control therapy&#xD;
  &#xD;
            -  a history of allergies to atropine.&#xD;
  &#xD;
            -  Patients were deemed inappropriate for trial participation by the lead investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>He Eye Hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110034</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Baird PN, Saw SM, Lanca C, Guggenheim JA, Smith Iii EL, Zhou X, Matsui KO, Wu PC, Sankaridurg P, Chia A, Rosman M, Lamoureux EL, Man R, He M. Myopia. Nat Rev Dis Primers. 2020 Dec 17;6(1):99. doi: 10.1038/s41572-020-00231-4.</citation>
      <PMID>33328468</PMID>
    </reference>
    <reference>
      <citation>He M, Huang W, Li Y, Zheng Y, Yin Q, Foster PJ. Refractive error and biometry in older Chinese adults: the Liwan eye study. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5130-6. doi: 10.1167/iovs.09-3455. Epub 2009 Jun 24.</citation>
      <PMID>19553618</PMID>
    </reference>
    <reference>
      <citation>Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, Johnson GJ, Seah SK. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2486-94.</citation>
      <PMID>10937558</PMID>
    </reference>
    <reference>
      <citation>Ciuffreda KJ, Vasudevan B. Nearwork-induced transient myopia (NITM) and permanent myopia--is there a link? Ophthalmic Physiol Opt. 2008 Mar;28(2):103-14. doi: 10.1111/j.1475-1313.2008.00550.x.</citation>
      <PMID>18339041</PMID>
    </reference>
    <reference>
      <citation>Vera-Diaz FA, Strang NC, Winn B. Nearwork induced transient myopia during myopia progression. Curr Eye Res. 2002 Apr;24(4):289-95. doi: 10.1076/ceyr.24.4.289.8418.</citation>
      <PMID>12324868</PMID>
    </reference>
    <reference>
      <citation>Lin Z, Vasudevan B, Ciuffreda KJ, Wang NL, Zhang YC, Rong SS, Qiao LY, Pang CC, Liang YB. Nearwork-induced transient myopia and parental refractive error. Optom Vis Sci. 2013 May;90(5):507-16. doi: 10.1097/OPX.0b013e31828deef1.</citation>
      <PMID>23538434</PMID>
    </reference>
    <reference>
      <citation>Yam JC, Zhang XJ, Zhang Y, Wang YM, Tang SM, Li FF, Kam KW, Ko ST, Yip BHK, Young AL, Tham CC, Chen LJ, Pang CP. Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report. Ophthalmology. 2022 Mar;129(3):308-321. doi: 10.1016/j.ophtha.2021.10.002. Epub 2021 Oct 7.</citation>
      <PMID>34627809</PMID>
    </reference>
    <reference>
      <citation>Yam JC, Li FF, Zhang X, Tang SM, Yip BHK, Kam KW, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report. Ophthalmology. 2020 Jul;127(7):910-919. doi: 10.1016/j.ophtha.2019.12.011. Epub 2019 Dec 21.</citation>
      <PMID>32019700</PMID>
    </reference>
    <reference>
      <citation>Guo L, Fan L, Tao J, Hua R, Yang Q, Gu H, Yu S, Li L, Zhao X. Use of Topical 0.01% Atropine for Controlling Near Work-Induced Transient Myopia: A Randomized, Double-Masked, Placebo-Controlled Study. J Ocul Pharmacol Ther. 2020 Mar;36(2):97-101. doi: 10.1089/jop.2019.0062. Epub 2019 Dec 3.</citation>
      <PMID>31800355</PMID>
    </reference>
    <reference>
      <citation>Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.</citation>
      <PMID>23303884</PMID>
    </reference>
    <reference>
      <citation>Jimenez R, Redondo B, Galan T, Machado P, Molina R, Vera J. Impact of dual-focus soft contact lens wear on near work-induced transient myopia. Clin Exp Optom. 2023 Apr;106(3):296-302. doi: 10.1080/08164622.2022.2029684. Epub 2022 Jan 24.</citation>
      <PMID>35073496</PMID>
    </reference>
    <reference>
      <citation>Chan CW, Wong D, Lam CL, McGhee S, Lai WW. Development of a Chinese version of the National Eye Institute Visual Function Questionnaire (CHI-VFQ-25) as a tool to study patients with eye diseases in Hong Kong. Br J Ophthalmol. 2009 Nov;93(11):1431-6. doi: 10.1136/bjo.2009.158428. Epub 2009 Jun 9.</citation>
      <PMID>19515645</PMID>
    </reference>
    <reference>
      <citation>Miura M, Inomata T, Nojiri S, Sung J, Nagao M, Shimazaki J, Midorikawa-Inomata A, Okumura Y, Fujio K, Akasaki Y, Kuwahara M, Huang T, Nakamura M, Iwagami M, Hirosawa K, Fujimoto K, Murakami A. Clinical efficacy of diquafosol sodium 3% versus hyaluronic acid 0.1% in patients with dry eye disease after cataract surgery: a protocol for a single-centre, randomised controlled trial. BMJ Open. 2022 Jan 31;12(1):e052488. doi: 10.1136/bmjopen-2021-052488.</citation>
      <PMID>35105626</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myopia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atropine</mesh_term>
    </intervention_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>
      <ipd_info_type>Statistical Analysis Plan (SAP)</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/NCT06034366
  org study id: atropine2023
  nct id: NCT06034366
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM)
        development and progression. Atropine eye drop is beneficial in reducing initial NITM and
        slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive
        0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM,
        cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular
        pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week,
        36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each
        follow-up visit. Adverse events also will be monitored and documented at each subsequent
        follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of
        NITM and its possible association with the progression of refractive change in Chinese myopic
        children.
  Myopia is a common condition that develops primarily during childhood and early adulthood
        when excessive elongation of the eye results in images of distant objects coming into focus
        in front of the retina, resulting in blurred distance vision. Myopia is the most common
        ocular disorder worldwide, with increasing prevalence over the past decades, predominantly in
        East Asia. Previous studies suggested that environmental factors, such as near-work demands,
        likely play an important role in myopia development in the younger population.
  
        Near work, a main environmental-based factor in the development and progression of permanent
        myopia (PM), induced via near work-induced transient myopia (NITM). Compared with PM, NITM
        refers to the prolonged period required for the accommodation of the eyes to return to a
        normal level after engaging in a sustained near task. It was proposed some years ago that
        NITM, which produces minor and chronic retinal defocus, may be one of many possible
        environmentally-based, myopigenic, contributory factors to permanent myopia.
  
        As a nonselective muscarinic antagonist, atropine eye drops with different concentrations
        have been reported to slow down the myopic progression in myopes. Recently, a two weeks study
        assessed the efficacy of a low-concentration of atropine (0.01%) on the initial NITM
        magnitude among Chinese myopic children. The results suggested 0.01% atropine reduced the
        initial NITM magnitude. However, the long-term efficacy of 0.01% atropine in treating NITM
        and the relationship between NITM and refractive change after treatment is still unclear.
  
        This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its
        possible association with the progression of refractive change in Chinese myopic children.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Nearwork-induced transient myopia (NITM) in diopter
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: WAM-5500; Grand Seiko, Japan, will be used to assess the NITM in diopter unit.
  measure: Spherical equivalent (SE) in diopter
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: WAM-5500; Grand Seiko, Japan, will be used to assess the SE of each eye in diopter unit.
  measure: Axial length (AL) in millimetre
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: Zeiss IOL Master 700 will be used to assess the AL of each eye in diopter unit.
  measure: 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: The NEI-VFQ-25 contains 25 questions: general health, general vision, ocular pain, distance, near tasks, dependency on others, role limitation, mental health, social function, driving, peripheral vision, and color vision difficulty. The answer is converted into a 100-point scale for each question, with 100 being the best and 0 the worst. One or more questions are specific to each subscale; therefore, the subscale score is the average of one or more specific questions. The Chinese version of the NEI-VFQ-25 questionnaire was used
  measure: Safety evaluation of best corrected visual acuity (BCVA)
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) chart will be used to assess BCVA of each eye.
  measure: Safety evaluation of pupil size
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: Pupil size in millimetres will be measured using OPD-Scan III, Nidek, Japan.
  measure: Safety evaluation of intraocular pressure
  time frame: At baseline, week 4, week 12, week 24, week 36, and week 48
  description: Intraocular pressure (IOP) in mmHg using a tonometry.
  arm group label: study group
  arm group type: Experimental
  description: Participants in the study group will use 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,
  arm group label: placebo eye drops
  arm group type: Other
  description: participants in the control group will utilize placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks.
  intervention type: Drug
  intervention name: 0.01% atropine
  description: 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,
  arm group label: study group
  intervention type: Other
  intervention name: 0.9% sodium chloride
  description: placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks
  arm group label: placebo eye drops
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: No
  facility: 
  country: China
  citation: Baird PN, Saw SM, Lanca C, Guggenheim JA, Smith Iii EL, Zhou X, Matsui KO, Wu PC, Sankaridurg P, Chia A, Rosman M, Lamoureux EL, Man R, He M. Myopia. Nat Rev Dis Primers. 2020 Dec 17;6(1):99. doi: 10.1038/s41572-020-00231-4.
  PMID: 33328468
  citation: He M, Huang W, Li Y, Zheng Y, Yin Q, Foster PJ. Refractive error and biometry in older Chinese adults: the Liwan eye study. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5130-6. doi: 10.1167/iovs.09-3455. Epub 2009 Jun 24.
  PMID: 19553618
  citation: Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, Johnson GJ, Seah SK. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2486-94.
  PMID: 10937558
  citation: Ciuffreda KJ, Vasudevan B. Nearwork-induced transient myopia (NITM) and permanent myopia--is there a link? Ophthalmic Physiol Opt. 2008 Mar;28(2):103-14. doi: 10.1111/j.1475-1313.2008.00550.x.
  PMID: 18339041
  citation: Vera-Diaz FA, Strang NC, Winn B. Nearwork induced transient myopia during myopia progression. Curr Eye Res. 2002 Apr;24(4):289-95. doi: 10.1076/ceyr.24.4.289.8418.
  PMID: 12324868
  citation: Lin Z, Vasudevan B, Ciuffreda KJ, Wang NL, Zhang YC, Rong SS, Qiao LY, Pang CC, Liang YB. Nearwork-induced transient myopia and parental refractive error. Optom Vis Sci. 2013 May;90(5):507-16. doi: 10.1097/OPX.0b013e31828deef1.
  PMID: 23538434
  citation: Yam JC, Zhang XJ, Zhang Y, Wang YM, Tang SM, Li FF, Kam KW, Ko ST, Yip BHK, Young AL, Tham CC, Chen LJ, Pang CP. Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report. Ophthalmology. 2022 Mar;129(3):308-321. doi: 10.1016/j.ophtha.2021.10.002. Epub 2021 Oct 7.
  PMID: 34627809
  citation: Yam JC, Li FF, Zhang X, Tang SM, Yip BHK, Kam KW, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report. Ophthalmology. 2020 Jul;127(7):910-919. doi: 10.1016/j.ophtha.2019.12.011. Epub 2019 Dec 21.
  PMID: 32019700
  citation: Guo L, Fan L, Tao J, Hua R, Yang Q, Gu H, Yu S, Li L, Zhao X. Use of Topical 0.01% Atropine for Controlling Near Work-Induced Transient Myopia: A Randomized, Double-Masked, Placebo-Controlled Study. J Ocul Pharmacol Ther. 2020 Mar;36(2):97-101. doi: 10.1089/jop.2019.0062. Epub 2019 Dec 3.
  PMID: 31800355
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  PMID: 35073496
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  PMID: 35105626
  responsible party type: Sponsor
  mesh term: Myopia
  mesh term: Atropine
  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
  ipd info type: Statistical Analysis Plan (SAP)