Status:
COMPLETED
Binocularly Balanced Viewing Study
Lead Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Conditions:
Amblyopia
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for...
Detailed Description
"Lazy eye" (amblyopia) is the commonest sight problem in children, affecting about one in 30 children. It is caused by a difference in spectacle prescription between the eyes and/or a squint (eye misa...
Eligibility Criteria
Inclusion
- Age between 3.0 and less than 8.0 years
- unilateral anisometropic, strabismic or combined mechanism amblyopia
- best-corrected crowded logMAR visual acuity (BCVA) in the amblyopic eye worse than 0.2logMar
- best corrected visual acuity in the better seeing eye 0.2 or better
- difference in best corrected visual acuity between the two eyes of 0.2 logMAR or more
- adapted to spectacles with no improvement in acuity in affected eye for two consecutive visits
- no previous treatment for amblyopia other than glasses
Exclusion
- ocular cause for reduced visual acuity
- inability to co-operate with assessment tests
- other developmental disorders or learning or neurological disability that would impact on adherence to treatment
- photopic epilepsy
- myopia with spherical equivalent of greater than -6.00DS
- previous intraocular surgery
- inability to perform a crowded letter logMAR visual acuity test using a clinical trials standard testing method (ATS-HOTV protocol), either by naming or by matching letters
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03754153
Start Date
October 28 2019
End Date
December 1 2021
Last Update
December 23 2021
Active Locations (1)
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1
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD