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

Shahid Beheshti University of Medical Sciences

Status: Unknown

Conditions: The New Treatment in Amblyopia Therapy

Treatments: Device: Interactive Binocular Treatment; Procedure: Patching Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03940222

SBMU.12345

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 2 patient groups, including a placebo group

I-BiT group

Experimental group

Description:

Amblyopic patients will play I-BiT games without patching.

Treatment:

Device: Interactive Binocular Treatment

Placebo group

Placebo Comparator group

Description:

Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.

Treatment:

Procedure: Patching Therapy