The Role of Interactive Binocular Treatment System in Amblyopia Therapy
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 6, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedApril 15, 2016
April 1, 2016
1.9 years
April 6, 2016
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity, Stereopsis
Two arms were under patching and Interactive Binocular Treatment (IBIT)
30 days
Study Arms (2)
Recommendation of Patching
ACTIVE COMPARATORPatients 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 COMPARATORPatients 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.
Interventions
Occlusion of a dominant eye with better best corrected visual acuity
Dissociation of two eyes with more foveal stimulation to the amblyopic eye
Eligibility Criteria
You may qualify if:
- BCVA \<= 0.3 LogMAR
You may not qualify if:
- Organic Amblyopia
- Age less than 4 years
- Nystagmus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Islamic Republic of Iran
Tehran, Iran
Related Publications (1)
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.
PMID: 27830207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhale Rajavi, Professor
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Shahid Beheshti Medical University
Study Record Dates
First Submitted
April 6, 2016
First Posted
April 15, 2016
Study Start
December 1, 2014
Primary Completion
November 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04