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

May 11, 2010 updated by: Singapore National Eye Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • SNEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Device: Hyperopic lens
+3 D glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myopia progression as measured by spherical equivalent, and axial length
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Collaborators

Singapore Eye Research Institute

Investigators

  • Principal Investigator: Audrey Chia, FRANZCO, Singapore National Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 16, 2006

Study Record Updates

Last Update Posted (Estimate)

May 12, 2010

Last Update Submitted That Met QC Criteria

May 11, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R473/22/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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