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

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03940222

Enrollment

Registered

2019-05-07

Start date

2019-08-31

Completion date

2020-11-30

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The New Treatment in Amblyopia Therapy

Brief 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.

Interventions

DEVICEInteractive 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.

PROCEDUREPatching Therapy

Patching of the dominant eye with better best corrected visual acuity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

3 Years to 10 Years

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

Design outcomes

Primary

Measure	Time frame
Best Corrected Visual Acuity	6 months

Countries

Iran

Contacts

Primary ContactHamideh Sabbaghi, PhD

sabbaghi.opt@gmail.com989120285930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026