Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia
NCT ID: NCT03940222
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
38 participants
INTERVENTIONAL
2019-08-31
2020-11-30
Brief Summary
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In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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I-BiT group
Amblyopic patients will play I-BiT games without patching.
Interactive Binocular Treatment
The specified system which stimulate the fovea of the amblyopic eye directly by detailed and movable objects, while the fixation of the non- amblyopic eye will be focused on fixed targets.
Placebo group
Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.
Patching Therapy
Patching of the dominant eye with better best corrected visual acuity
Interventions
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Interactive Binocular Treatment
The specified system which stimulate the fovea of the amblyopic eye directly by detailed and movable objects, while the fixation of the non- amblyopic eye will be focused on fixed targets.
Patching Therapy
Patching of the dominant eye with better best corrected visual acuity
Eligibility Criteria
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Inclusion Criteria
* A difference of two BCVA lines of Snellen between the two eyes
Exclusion Criteria
* Bilateral amblyopia
* BCVA less than 20/200
* Eccentric fixation
* Nystagmus
* Ocular deviation more than 10 prism diopter (pd)
* Organic amblyopia
* Uncooperative children those with
* Mental and physical disability
* Systemic diseases
3 Years
10 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Hamideh Sabbaghi
PhD student, Teacher Assistant
Locations
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Hamideh Sabbaghi
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Hamideh Sabbaghi
Role: primary
Other Identifiers
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SBMU.12345
Identifier Type: -
Identifier Source: org_study_id
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