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

NCT ID: NCT00400140

Last Updated: 2010-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-10-31

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 changes in spherical equivalent refraction 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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Group Type: EXPERIMENTAL

Hyperopic lens

Intervention Type: DEVICE

+3 D glasses

Interventions

Hyperopic lens

+3 D glasses

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore Eye Research Institute

OTHER

Sponsor Role: collaborator

Singapore National Eye Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Singapore National Eye Centre

Principal Investigators

Audrey Chia, FRANZCO

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Center

Locations

SNEC

Singapore, , Singapore

Countries

Singapore

Other Identifiers

R473/22/2006

Identifier Type: -

Identifier Source: org_study_id