NCT03940222

Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• The New Treatment in Amblyopia Therapy

Interventions

Type	Name	Description
DEVICE	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.
PROCEDURE	Patching Therapy	Patching of the dominant eye with better best corrected visual acuity

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-03-01
• Completion: 2020-11-01
• First posted: 2019-05-07
• Last updated: 2019-05-07

Locations

1 site across 1 country: Iran