Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages
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|ClinicalTrials.gov Identifier: NCT02113709|
Recruitment Status : Unknown
Verified April 2014 by Dr. Sameera Irfan, Mughal Eye Trust Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age.
Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia Strabismus||Device: Occlusion therapy by Eye Patch Device: Occlusion therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at All Ages|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||June 2014|
Experimental: Visual improvement
To see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia.
Device: Occlusion therapy by Eye Patch
The good eye was occluded by a stick-on eye patch to stimulate the amblyopic eye and its neural connections to learn to see again.
Device: Occlusion therapy
To see how much improvement in visual acuity occurs by full-time occlusion therapy.
Other Name: eye patch (commercially pre-packed)
- Visual Acuity improvement [ Time Frame: 3 months ]Full-time occlusion therapy of good eye was performed for 2-3 months while closely monitoring the vision of both the good and the amblyopic eye. Vision was assessed by EDTRS Charts as well as Snellen's Chart.
- improvement in stereopsis [ Time Frame: 1 year ]as equal visual acuity is attained by both eyes, the stereopsis also improves. It was assessed by satandardized TNO plates with the patient wearing polarized glasses over their own corrective spectacles.
- Does the patched good eye develop occlusion amblyopia [ Time Frame: 3 months ]The vision of patched good eye was meticulously monitored to note the development of occlusion amblyopia
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): NCT02113709
|Mughal Eye Trust Hospital|
|Lahore, Punjab, Pakistan, 54770|
|Principal Investigator:||Sameera Irfan, FRCS||Mughal Eye Trust Hospital, Lahore, Pakistan|