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Sponsored by: |
Singapore National Eye Centre |
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Information provided by: | Singapore National Eye Centre |
ClinicalTrials.gov Identifier: | NCT00371124 |
The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.
Condition | Intervention | Phase |
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Myopia |
Drug: Atropine Eye drops |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children |
Estimated Enrollment: | 400 |
Study Start Date: | March 2006 |
A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children
Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits.
STUDY DESIGN This study consists of 2 phases, each with a different design. Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years, with myopia of -2.00 D or worse in each eye, and from whom assent and parental/guardian consent have been obtained, will be randomised to receive 0.5% atropine, 0.1% atropine or 0.01% atropine once nightly in both eyes. Participants will be assigned to treatment in the ratio of 2:2:1, respectively. Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months.
Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment. Those children who demonstrate myopia progression of –0.5 D or more, at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes. The appropriate dose will be determined by analysis of the data from Phase I of the study. Treatment will be for a further 2 years and all children, including those not receiving treatment, will be reviewed every 6 months.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Donald Tan, FRCS | +65 6322 4503 | snecdt@pacific.net.sg |
Singapore | |
Singapore Eye Research Institute | Recruiting |
Singapore, Singapore | |
Contact: Donald Tan, FRCS snecdt@pacific.net.sg | |
Principal Investigator: Wei Han Chua, FRCS | |
Sub-Investigator: Allan Fong, MRCOphth |
Principal Investigator: | Donald Tan, FRCS | SNEC, SERI |
Principal Investigator: | Wei Han Chua, FRCS | SNEC, SERI |
Study ID Numbers: | R359/17/2004 |
Study First Received: | August 30, 2006 |
Last Updated: | August 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00371124 History of Changes |
Health Authority: | Singapore: Domain Specific Review Boards |
Myopia treatment Atropine |
Neurotransmitter Agents Cholinergic Antagonists Eye Diseases Disease Progression Adjuvants, Immunologic Anesthetics Anti-Asthmatic Agents Myopia Tetrahydrozoline |
Cardiovascular Agents Cholinergic Agents Muscarinic Antagonists Mydriatics Anti-Arrhythmia Agents Peripheral Nervous System Agents Bronchodilator Agents Refractive Errors Atropine |
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Eye Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Myopia Cardiovascular Agents Cholinergic Agents Pharmacologic Actions |
Muscarinic Antagonists Adjuvants, Anesthesia Mydriatics Autonomic Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents Refractive Errors Atropine |