Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The New Treatment in Amblyopia Therapy
- Sponsor
- Shahid Beheshti University of Medical Sciences
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Best Corrected Visual Acuity
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM.
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.
Investigators
Hamideh Sabbaghi
PhD student, Teacher Assistant
Shahid Beheshti University of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye
- •A difference of two BCVA lines of Snellen between the two eyes
Exclusion Criteria
- •A history of penalization one month prior to the study
- •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
Outcomes
Primary Outcomes
Best Corrected Visual Acuity
Time Frame: 6 months