Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia
Primary Purpose
The New Treatment in Amblyopia Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Interactive Binocular Treatment
Patching Therapy
Sponsored by
About this trial
This is an interventional treatment trial for The New Treatment in Amblyopia Therapy
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
Sites / Locations
- Hamideh SabbaghiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
I-BiT group
Placebo group
Arm Description
Amblyopic patients will play I-BiT games without patching.
Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT03940222
First Posted
May 3, 2019
Last Updated
May 4, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03940222
Brief Title
Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia
Official Title
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The New Treatment in Amblyopia Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I-BiT group
Arm Type
Experimental
Arm Description
Amblyopic patients will play I-BiT games without patching.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.
Intervention Type
Device
Intervention Name(s)
Interactive Binocular Treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Patching Therapy
Intervention Description
Patching of the dominant eye with better best corrected visual acuity
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamideh Sabbaghi, PhD
Phone
989120285930
Email
sabbaghi.opt@gmail.com
Facility Information:
Facility Name
Hamideh Sabbaghi
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamideh Sabbaghi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia
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