Status:
COMPLETED
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Lead Sponsor:
Singapore National Eye Centre
Collaborating Sponsors:
Singapore Eye Research Institute
Conditions:
Myopia
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by chang...
Detailed Description
Recent results on animal models of myopia suggest that the eye has the ability to detect the overall sign of defocus of images falling on the retina, with myopic defocus imposed by the fitting of plus...
Eligibility Criteria
Inclusion
- Children aged 6 to 12 years
- Refractive error of spherical equivalent -1.00 D to -6.00D in each eye as measured by cycloplegic autorefraction
- Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
- Astigmatism of less than or equal to -1.50 D as measured by non-cycloplegic or cycloplegic autorefraction
- Distance vision correctable to logMAR 0.1 or better in both eyes
- Normal intraocular pressure of not greater than 21 mmHg
- Normal ocular health other than myopia
- In good general health
- Willing and able to comply with scheduled visits and other study procedures
Exclusion
- Baseline Anisometropia of \> 1.5D
- Ocular or systemic diseases which may affect vision or refractive error
- Defective binocular function or stereopsis
- Amblyopia or manifest strabismus including intermittent tropia
- Previous or current use of atropine or pirenzepine
- Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
- Allergy to cyclopentolate, proparacaine and benzalkonium chloride
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00400140
Start Date
November 1 2006
End Date
October 1 2008
Last Update
May 12 2010
Active Locations (1)
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1
SNEC
Singapore, Singapore, 168751