The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Shahid Beheshti University of Medical Sciences

Status: Unknown

Conditions: Amblyopia

Treatments: Device: Interactive Binocular Treatment System; Other: Patching Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02740725

sbmu.rec.1393.591

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BCVA <= 0.3 LogMAR

Exclusion criteria

• Organic Amblyopia
• Age less than 4 years
• Nystagmus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Recommendation of Patching

Active Comparator group

Description:

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.

Treatment:

Other: Patching Therapy

Recommendation of Patching and interactive binocular treatment

Active Comparator group

Description:

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.

Treatment:

Other: Patching Therapy

Device: Interactive Binocular Treatment System