The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Not Applicable

• Conditions: Amblyopia
• Interventions: Other: Patching Therapy; Device: Interactive Binocular Treatment System

• Registration Number: NCT02740725
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy.

Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.

Detailed Description

In this clinical trial study, our case group will receive I-BiTTM in the format of three playing games which have been designed suitable to the age of our cases. The mechanism of I-BiTTM has been designed in three playing games with inducing more foveal stimulation for the amblyopic eye through presentation of movable targets with more detailed. In addition, unmovable targets will presented to the non-amblyopic eyes. Playing games were continued 30 minutes in each session for 5 days in each week within one month.

Study Timeline

• Study Start: 2014-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• BCVA <= 0.3 LogMAR

Exclusion Criteria

• Organic Amblyopia
• Age less than 4 years
• Nystagmus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recommendation of Patching and interactive binocular treatment	Interactive Binocular Treatment System	Patients will receive interactive binocular treatment addition to patch therapy in the least of 4 to 5 days of a week within 20-30 minutes in each day during one month.
Recommendation of Patching	Patching Therapy	Patients will receive two hours of patching in the case of one line difference of best corrected visual acuity(BCVA) between two eyes during one month.
Recommendation of Patching and interactive binocular treatment	Patching Therapy	Patients will receive interactive binocular treatment addition to patch therapy in the least of 4 to 5 days of a week within 20-30 minutes in each day during one month.

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity, Stereopsis	30 days	Two arms were under patching and Interactive Binocular Treatment (IBIT)

Trial Locations

Locations (1)

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