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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recommendation of Patching | Active Comparator | 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. |
|
| Recommendation of Patching and interactive binocular treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patching Therapy | Other | Occlusion of a dominant eye with better best corrected visual acuity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity, Stereopsis | Two arms were under patching and Interactive Binocular Treatment (IBIT) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamideh Sabbaghi, MS | Contact | +98 912 02805930 | sabbaghi_h@yahoo.com | |
| Hamideh Sabbaghi, MS | Contact | +9891554518406 | sabbaghi_h@sbmu.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Zhale Rajavi, Professor | Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Islamic Republic of Iran | Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27830207 | Derived | Rajavi Z, Sabbaghi H, Amini Sharifi E, Behradfar N, Yaseri M. The role of Interactive Binocular Treatment system in amblyopia therapy. J Curr Ophthalmol. 2016 Aug 9;28(4):217-222. doi: 10.1016/j.joco.2016.07.005. eCollection 2016 Dec. |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Interactive Binocular Treatment System | Device | Dissociation of two eyes with more foveal stimulation to the amblyopic eye |
|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |