Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia

The New Treatment in Amblyopia Therapy Clinical Trial

Official title:

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940222
• Other study ID #: SBMU.12345
• Status: Recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: November 2020

Study information

• Verified date: May 2019
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Hamideh Sabbaghi, PhD
• Phone: 989120285930
• Email: sabbaghi.opt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM.

In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye

• A difference of two BCVA lines of Snellen between the two eyes

Exclusion Criteria:

• A history of penalization one month prior to the study

• Bilateral amblyopia

• BCVA less than 20/200

• Eccentric fixation

• Nystagmus

• Ocular deviation more than 10 prism diopter (pd)

• Organic amblyopia

• Uncooperative children those with

• Mental and physical disability

• Systemic diseases

Related Conditions & MeSH terms

• Amblyopia
• The New Treatment in Amblyopia Therapy

Intervention

Device:
• Interactive Binocular Treatment
The specified system which stimulate the fovea of the amblyopic eye directly by detailed and movable objects, while the fixation of the non- amblyopic eye will be focused on fixed targets.

Procedure:
• Patching Therapy
Patching of the dominant eye with better best corrected visual acuity

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hamideh Sabbaghi	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		6 months