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Clinical Trials/NCT03940222
NCT03940222
Unknown
Not Applicable

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Shahid Beheshti University of Medical Sciences1 site in 1 country38 target enrollmentAugust 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
The New Treatment in Amblyopia Therapy
Sponsor
Shahid Beheshti University of Medical Sciences
Enrollment
38
Locations
1
Primary Endpoint
Best Corrected Visual Acuity
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2019
End Date
November 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hamideh Sabbaghi

PhD student, Teacher Assistant

Shahid Beheshti University of Medical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

Best Corrected Visual Acuity

Time Frame: 6 months

Study Sites (1)

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