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

Not Applicable

• Conditions: The New Treatment in Amblyopia Therapy
• Interventions: Device: Interactive Binocular Treatment; Procedure: Patching Therapy

• Registration Number: NCT03940222
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-04
• Last Update Submitted: 2019-05-04
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07
• Study Start: 2019-08
• Primary Completion: 2020-03
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-BiT group	Interactive Binocular Treatment	Amblyopic patients will play I-BiT games without patching.
Placebo group	Patching Therapy	Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	6 months

Trial Locations

Locations (1)

Hamideh Sabbaghi; 🇮🇷 Tehran, Iran, Islamic Republic of