The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Amblyopia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02740725
• Other study ID #: sbmu.rec.1393.591
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2016
• Last updated: April 14, 2016
• Start date: December 2014

Study information

• Verified date: April 2016
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Hamideh Sabbaghi, MS
• Phone: +98 912 02805930
• Email: sabbaghi_h[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee of the School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• BCVA <= 0.3 LogMAR

Exclusion Criteria:

• Organic Amblyopia

• Age less than 4 years

• Nystagmus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Other:
• Patching Therapy
Occlusion of a dominant eye with better best corrected visual acuity

Device:
• Interactive Binocular Treatment System
Dissociation of two eyes with more foveal stimulation to the amblyopic eye

Locations

Country	Name	City	State
Iran, Islamic Republic of	Islamic Republic of Iran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity, Stereopsis	Two arms were under patching and Interactive Binocular Treatment (IBIT)	30 days	Yes