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The Role of Interactive Binocular Treatment System in Amblyopia Therapy

NCT02740725 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-04-15

No results posted yet for this study

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.

Conditions

  • Amblyopia

Interventions

OTHER

Patching Therapy

Occlusion of a dominant eye with better best corrected visual acuity

DEVICE

Interactive Binocular Treatment System

Dissociation of two eyes with more foveal stimulation to the amblyopic eye

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Principal Investigators

  • Zhale Rajavi, Professor · Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-11-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740725 on ClinicalTrials.gov