Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
|ClinicalTrials.gov Identifier: NCT00371124|
Recruitment Status : Unknown
Verified May 2010 by Singapore National Eye Centre.
Recruitment status was: Active, not recruiting
First Posted : September 1, 2006
Last Update Posted : August 31, 2010
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Drug: Atropine Eye drops||Phase 2 Phase 3|
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.
- Phase I: 2 years with 8 scheduled visits
- Phase II: 3 years with 7 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2006|
- Spherical equivalent refraction determined by cycloplegic autorefraction
- Axial length determined by non-contact partial coherence interferometry
- Ocular symptoms
- Induced cycloplegia assessed by near acuity and amplitude of accommodation tests
- Pupil reactivity and diameter assessment
- Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry
- Posterior segment changes assessed by fundus photography and ophthalmoscopy
- Retinal function assessed by distance acuity test and electroretinography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371124
|Singapore Eye Research Institute|
|Principal Investigator:||Donald Tan, FRCS||SNEC, SERI|
|Principal Investigator:||Wei Han Chua, FRCS||SNEC, SERI|