Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMay 7, 2019
May 1, 2019
7 months
May 3, 2019
May 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity
6 months
Study Arms (2)
I-BiT group
EXPERIMENTALAmblyopic patients will play I-BiT games without patching.
Placebo group
PLACEBO COMPARATORAmblyopic patients will patch their dominant eye and they will play placebo I-BiT games.
Interventions
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.
Patching of the dominant eye with better best corrected visual acuity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamideh Sabbaghi
Tehran, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student, Teacher Assistant
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 7, 2019
Study Start
August 1, 2019
Primary Completion
March 1, 2020
Study Completion
November 1, 2020
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share