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

NCT03940222 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-05-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2020-03-31
Completion
2020-11-30

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 NCT03940222 on ClinicalTrials.gov