Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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): NCT00371124
|Singapore Eye Research Institute|
|Principal Investigator:||Donald Tan, FRCS||SNEC, SERI|
|Principal Investigator:||Wei Han Chua, FRCS||SNEC, SERI|