Status:
COMPLETED
Effectiveness of Telescopic Magnification in the Treatment of Amblyopia
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Amblyopia
Eligibility:
All Genders
4-17 years
Phase:
PHASE1
PHASE2
Brief Summary
Amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. The standard treatment for amblyopia consists of patching or pharmacological penalizati...
Detailed Description
The goal of the present investigation was to conduct a prospective randomized clinical study to further evaluate the effectiveness of telescopic magnification plus patching vs patching alone on differ...
Eligibility Criteria
Inclusion
- Aged 4-17 years
- Strabismic, refractive (anisometropic), isometropic or mixed mechanism amblyopia
- Strabismic amblyopia is defined as amblyopia (1) in the presence of either an inability to maintain parallel visual axes (heterotropia) at distance or near fixation or both, or a history of strabismus surgery (or botulinum injection), and (2) in the absence of refractive error meeting the criteria below for mixed mechanism amblyopia
- Refractive/Anisometropic amblyopia is defined as amblyopia in the presence of a difference in refractive error between the two eyes (anisometropia) of ≥0.5 diopter (D) of spherical equivalent or ≥1.5D of difference in astigmatism in any meridian, with no measurable heterophoria at distance or near fixation, which persisted after 12 weeks of spectacle correction
- Isometropic amblyopia is defined as amblyopia in the presence a refractive error ≥5.0D of spherical equivalent in both eyes, but not meeting the criteria of anisometropic amblyopia
- Mixed mechanism strabismic and refractive amblyopia is defined as the presence of both strabismic and anisometropic types of amblyopia
- Ability to read the ETDRS letter chart
- Visual acuity between 0.3 and 1.3 logMAR (i.e., between 20/40 and 20/400) in the amblyopic eye
- Visual acuity of 0.3 logMAR (i.e., 20/40) or better in the sound eye
- Interocular acuity difference ≥0.3 logMAR
- Appropriate refractive error correction for at least 12 weeks
Exclusion
- Presence of an ocular cause of reduced visual acuity
- Myopia with a spherical equivalent of -6.0D or more, due to the likely presence of pathological myopia
- Prior intraocular surgery
- Known skin reaction to patch or bandage adhesive
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00970554
Start Date
December 1 2007
End Date
May 1 2009
Last Update
August 27 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada