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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-BiTâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-BiT group | Experimental | Amblyopic patients will play I-BiT games without patching. |
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| Placebo group | Placebo Comparator | Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Binocular Treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamideh Sabbaghi, PhD | Contact | 989120285930 | sabbaghi.opt@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamideh Sabbaghi | Recruiting | Tehran | Iran |
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| Patching Therapy | Procedure | Patching of the dominant eye with better best corrected visual acuity |
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