The Role of Interactive Binocular Treatment System in Amblyopia Therapy

NCT ID: NCT02740725

Last Updated: 2016-04-15

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Patching Therapy

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Patching Therapy

Intervention Type OTHER

Occlusion of a dominant eye with better best corrected visual acuity

Interactive Binocular Treatment System

Intervention Type DEVICE

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

Intervention Type OTHER

Interactive Binocular Treatment System

Dissociation of two eyes with more foveal stimulation to the amblyopic eye

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BCVA \<= 0.3 LogMAR

Exclusion Criteria

* Organic Amblyopia
* Age less than 4 years
* Nystagmus
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamideh Sabbaghi

Shahid Beheshti Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Hamideh Sabbaghi, MS

Role: CONTACT

+98 912 02805930

Hamideh Sabbaghi, MS

Role: CONTACT

+9891554518406

Facility Contacts

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Hamideh Sabbaghi, MS

Role: primary

+989120285930

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.

Reference Type DERIVED
PMID: 27830207 (View on PubMed)

Other Identifiers

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sbmu.rec.1393.591

Identifier Type: -

Identifier Source: org_study_id

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