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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Hyperopic lens
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, defocus

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SNEC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Myopia progression as measured by spherical equivalent, and axial length

Secondary Outcome Measures

Full Information

First Posted
November 15, 2006
Last Updated
May 11, 2010
Sponsor
Singapore National Eye Centre
Collaborators
Singapore Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00400140
Brief Title
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Official Title
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Singapore National Eye Centre
Collaborators
Singapore Eye Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, defocus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hyperopic lens
Intervention Description
+3 D glasses
Primary Outcome Measure Information:
Title
Myopia progression as measured by spherical equivalent, and axial length
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Chia, FRANZCO
Organizational Affiliation
Singapore National Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNEC
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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