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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400140
First Posted: November 16, 2006
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Singapore Eye Research Institute
Information provided by:
Singapore National Eye Centre
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 [ Time Frame: 12 month ]

Estimated Enrollment: 30
Study Start Date: November 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Hyperopic lens
+3 D glasses

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400140


Locations
Singapore
SNEC
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Singapore Eye Research Institute
Investigators
Principal Investigator: Audrey Chia, FRANZCO Singapore National Eye Center
  More Information

Responsible Party: Audrey Chia, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00400140     History of Changes
Other Study ID Numbers: R473/22/2006
First Submitted: November 15, 2006
First Posted: November 16, 2006
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Singapore National Eye Centre:
Myopia, defocus

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases