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The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

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ClinicalTrials.gov Identifier: NCT03140358
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Audrey Chia Wei-Lin, Singapore National Eye Centre

Brief Summary:
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine sulfate 0.01% Drug: Placebo Phase 3

Detailed Description:
High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : May 2, 2021
Estimated Study Completion Date : May 2, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Premyopia atropine
On Atropine 0.01%
Drug: Atropine sulfate 0.01%
Atropine 0.01%

Placebo Comparator: Premyopia placebo
On placebo
Drug: Placebo
placebo

Active Comparator: Low myopia atropine
On Atropine 0.01% daily or every other day
Drug: Atropine sulfate 0.01%
Atropine 0.01%

Placebo Comparator: Low myopia placebo
On placebo
Drug: Placebo
placebo




Primary Outcome Measures :
  1. Spherical Equivalent [ Time Frame: 3.5 years ]
    SE


Secondary Outcome Measures :
  1. Axial Length [ Time Frame: 3.5 years ]
    AL



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  1. One parent with myopia (<-3D in at least one eye)
  2. SE +1.00D to -1.50D
  3. Astigmatism < = 1.50D
  4. Distance vision logMAR 0.2 or better in both eyes
  5. Intraocular pressure of not greater than 21 mmHg
  6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion Criteria:

  1. Any eye or systemic disease that affect vision or refractive error
  2. Conditions where topical atropine contraindicated
  3. Previous use of atropine or pirenzepine
  4. Known past/current amblyopia or strabismus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140358


Contacts
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Contact: Su Ann Tay +6593395137 tay.su.ann@singhealth.com.sg

Locations
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Singapore
Singapore eye research institute Recruiting
Singapore, Singapore, 423699
Contact: Audrey Chia         
Sponsors and Collaborators
Singapore National Eye Centre
National Medical Research Council (NMRC), Singapore
Investigators
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Principal Investigator: Audrey Chia Singapore National Eye Center
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Responsible Party: Audrey Chia Wei-Lin, Adjuct Associate Professor, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT03140358    
Other Study ID Numbers: R1359/45/2016
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action