The Role of Interactive Binocular Treatment System in Amblyopia Therapy
NCT ID: NCT02740725
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Recommendation of Patching
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.
Patching Therapy
Occlusion of a dominant eye with better best corrected visual acuity
Recommendation of Patching and interactive binocular treatment
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.
Patching Therapy
Occlusion of a dominant eye with better best corrected visual acuity
Interactive Binocular Treatment System
Dissociation of two eyes with more foveal stimulation to the amblyopic eye
Interventions
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Patching Therapy
Occlusion of a dominant eye with better best corrected visual acuity
Interactive Binocular Treatment System
Dissociation of two eyes with more foveal stimulation to the amblyopic eye
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Age less than 4 years
* Nystagmus
4 Years
10 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Hamideh Sabbaghi
Shahid Beheshti Medical University
Principal Investigators
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Zhale Rajavi, Professor
Role: STUDY_DIRECTOR
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Locations
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Islamic Republic of Iran
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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sbmu.rec.1393.591
Identifier Type: -
Identifier Source: org_study_id
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