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

May 4, 2019 updated by: Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: I-BiT group
Amblyopic patients will play I-BiT games without patching.
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.
PLACEBO_COMPARATOR: Placebo group
Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.
Procedure: Patching Therapy
Patching of the dominant eye with better best corrected visual acuity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 4, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 4, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU.12345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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