The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Study Overview
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Brief Summary
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Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy. Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.

Detailed Description
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In this clinical trial study, our case group will receive I-BiTTM in the format of three playing games which have been designed suitable to the age of our cases. The mechanism of I-BiTTM has been designed in three playing games with inducing more foveal stimulation for the amblyopic eye through presentation of movable targets with more detailed. In addition, unmovable targets will presented to the non-amblyopic eyes. Playing games were continued 30 minutes in each session for 5 days in each week within one month.

Conditions
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Amblyopia

Intervention / Treatment
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* Other: Patching Therapy
* Device: Interactive Binocular Treatment System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BCVA <= 0.3 LogMAR Exclusion Criteria: Organic Amblyopia Age less than 4 years Nystagmus

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recommendation of Patching<br>Patients will receive two hours of patching in the case of one line difference of best corrected visual acuity(BCVA) between two eyes during one month. | Other: Patching Therapy<br>* Occlusion of a dominant eye with better best corrected visual acuity<br>|
| Active Comparator: Recommendation of Patching and interactive binocular treatment<br>Patients will receive interactive binocular treatment addition to patch therapy in the least of 4 to 5 days of a week within 20-30 minutes in each day during one month. | Other: Patching Therapy<br>* Occlusion of a dominant eye with better best corrected visual acuity<br>Device: Interactive Binocular Treatment System<br>* Dissociation of two eyes with more foveal stimulation to the amblyopic eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity, Stereopsis | Two arms were under patching and Interactive Binocular Treatment (IBIT) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amblyopia, Interaction Binocular Treatment (I-BiTTM), Patch Therapy