Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children

This study is currently recruiting participants.

Verified by Singapore National Eye Centre, November 2006

Sponsors and Collaborators:	Singapore National Eye Centre Singapore Eye Research Institute
Information provided by:	Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT00400140

Purpose

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.

Condition	Intervention
Myopia	Device: Hyperopic lens

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:

Myopia progression as measured by spherical equivalent, and axial length

Estimated Enrollment:	30
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2008

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

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400140

Locations

Singapore
SNEC	Recruiting
Singapore, Singapore, 168751
Contact: Audrey Chia, FRANZCO (65) 62277255 wla_chia@yahoo.com
Contact: WeiHan Chia, FRCO (65) 62277255 wei_han_chua@snec.com.sg
Principal Investigator: Wei Han Chua, FRCO

Sponsors and Collaborators

Singapore National Eye Centre

Singapore Eye Research Institute

Investigators

Principal Investigator:

Audrey Chia, FRANZCO

Singapore National Eye Center

More Information

Study ID Numbers:	R473/22/2006
Study First Received:	November 15, 2006
Last Updated:	November 15, 2006
ClinicalTrials.gov Identifier:	NCT00400140
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by Singapore National Eye Centre:

Myopia, defocus

Study placed in the following topic categories:

Eye Diseases
Disease Progression
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 16, 2009