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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

November 15, 2006
May 11, 2010
November 2006
October 2008   (final data collection date for primary outcome measure)
Myopia progression as measured by spherical equivalent, and axial length [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Myopia progression as measured by spherical equivalent, and axial length
Complete list of historical versions of study NCT00400140 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Myopia
Device: Hyperopic lens
+3 D glasses
Experimental: A
Intervention: Device: Hyperopic lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00400140
R473/22/2006
Not Provided
Audrey Chia, Singapore National Eye Centre
Singapore National Eye Centre
Singapore Eye Research Institute
Principal Investigator: Audrey Chia, FRANZCO Singapore National Eye Center
Singapore National Eye Centre
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP