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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:
Collaborator:
Singapore Eye Research Institute
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00400140
First received: November 15, 2006
Last updated: May 11, 2010
Last verified: May 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Audrey Chia, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00400140     History of Changes
Other Study ID Numbers: R473/22/2006
Study First Received: November 15, 2006
Last Updated: May 11, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore National Eye Centre:
Myopia, defocus

Additional relevant MeSH terms:
Myopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 20, 2014