Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Information source: Singapore National Eye Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myopia
Intervention: Hyperopic lens (Device)
Phase: N/A
Status: Completed
Sponsored by: Singapore National Eye Centre Official(s) and/or principal investigator(s): Audrey Chia, FRANZCO, Principal Investigator, Affiliation: Singapore National Eye Center
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 changes in spherical equivalent refraction and axial length.
Clinical Details
Official title: Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Myopia progression as measured by spherical equivalent, and axial length
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-lenses halting or slowing axial elongation of the eye. In the animal models,
these STOP growth signals have been shown to be particularly strong - with brief periods of
high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic
defocus in promoting eye growth. These results therefore suggest a novel strategy for
preventing the progression of myopia in children - the imposition of high levels of myopia
for brief periods of time. This approach is conceptually distinct from under-correction,
which imposes chronic mild myopic defocus.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Children aged 6 to 12 years
2. Refractive error of spherical equivalent - 1. 00 D to -6. 00D in each eye as measured by
cycloplegic autorefraction
3. 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
4. Astigmatism of less than or equal to - 1. 50 D as measured by non-cycloplegic or
cycloplegic autorefraction
5. Distance vision correctable to logMAR 0. 1 or better in both eyes
6. Normal intraocular pressure of not greater than 21 mmHg
7. Normal ocular health other than myopia
8. In good general health
9. Willing and able to comply with scheduled visits and other study procedures
Exclusion Criteria:
1. Baseline Anisometropia of > 1. 5D
2. Ocular or systemic diseases which may affect vision or refractive error
3. Defective binocular function or stereopsis
4. Amblyopia or manifest strabismus including intermittent tropia
5. Previous or current use of atropine or pirenzepine
6. Any other conditions precluding adherence to the protocol including unwillingness to
refrain from contact lens wear for the duration of the study
7. Allergy to cyclopentolate, proparacaine and benzalkonium chloride
Locations and Contacts
SNEC, Singapore 168751, Singapore
Additional Information
Starting date: November 2006
Last updated: May 11, 2010
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