Interactive Binocular Treatment (I- BiT) in Adult Patients With Anisometropic Amblyopia

Amblyopia is one of the common, preventable and treatable causes of decreased acuity of one or both eyes without a specific organic cause. Common treatments include optical correction, patching (closing the healthy eye), perceptual learning, and drug treatments. The patient's low cooperation, reduction in effectiveness and long treatment period of common methods have led to the design of new treatments that eliminate these disadvantages, among which binocular vision treatments can be mentioned. The purpose of this study is to apply a new and innovative method under binocular conditions in the treatment of anisometropic amblyopia in adults. In this randomized clinical trial study, 30 people (15 patients in the case group and 15 patients in the control group) aged 18 to 40 years with amblyopia (decrease in best corrected vision worse than 0.3 logarithmic units in one of the eyes or the difference of the corrected minimum visual acuity of two lines between two eyes) in the form of two groups of 15 people (case and control) will be included in the study. Patients will be randomly divided into two groups: case and control. Interactive Binocular Treatment (I-BiT) is used in the case group and usual games without I-BiT system are used as placebo in the other group. For this purpose, the games will be presented in the control group in such a way that the two eyes will not be dissociated and the patient will see all the targets in the same way with his two eyes. I-BiT is a new method for the treatment of amblyopia in which a person plays age-appropriate games using special glasses in a 3D space. The stimuli are shown differently to the two eyes and both eyes are involved in the treatment process. The selection of people in two groups will be such that background variables such as age, sex, as well as the severity of amblyopia or vision loss in the two groups are the same and confounding factors are under control. First, all eye examinations such as measuring visual acuity, lateral vision, checking refractive errors with and without cycloplegic drops, checking the alignment of visual axes, and also checking the anterior and posterior segments of the eye are performed. After the definitive diagnosis of amblyopia, people in both groups will be asked to use the given virtual games in the same way for one month, 5 sessions per week, each session for 30 minutes. In order to control the amount of use of computer games by patients, the duration of time that people use games will be controlled and recorded online using software by design engineers. Patients will be examined before treatment, one month after treatment and also one month after stopping treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Device: Interactive Binocular Treatment

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamideh Faculty member, Assistant Professor; Phone Number: 989120285930; Email: sabbaghi.opt@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 16666
    • Hamideh Sabbaghi
    • Contact: Hamideh Sabbaghi; Phone Number: 989120285930; Email: sabbaghi.opt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

1. Age range from 18 to 40 years
2. Best corrected visual acuity of 0.3 log units or worse in one eye
3. Cases of mild and moderate anisometropic amblyopia (BCVA≤0.3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interactive Binocular Treatment; Patients in this arm will receive the Interactive Binocular Treatment therapy as an intervention	Device: Interactive Binocular Treatment; Patients in the intervention group will be asked to play the games which will be designed based on the Interactive Binocular Treatment System and the patients in the placebo group will be asked to play games without the Interactive Binocular Treatment System.
Placebo Comparator: Placebo; Patients in this arm will receive no active treatment	Device: Interactive Binocular Treatment; Patients in the intervention group will be asked to play the games which will be designed based on the Interactive Binocular Treatment System and the patients in the placebo group will be asked to play games without the Interactive Binocular Treatment System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	The changes of the best corrected visual acuity after one month therapy will be measured as the primary outcome measure.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stereopsis	The changes of stereopsis will be assessed after one month therapy.	one month

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): December 29, 2025

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Amblyopia
• Other Study ID Numbers: IR.SBMU.RETECH.REC.1402.438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No