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

NCT ID: NCT07103473

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2025-12-29

Brief Summary

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.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Interactive Binocular Treatment

Patients in this arm will receive the Interactive Binocular Treatment therapy as an intervention

Group Type: ACTIVE_COMPARATOR

Interactive Binocular Treatment

Intervention Type: DEVICE

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

Patients in this arm will receive no active treatment

Group Type: PLACEBO_COMPARATOR

Interactive Binocular Treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hamideh Sabbaghi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hamideh Sabbaghi

Tehran, Tehran Province, Iran

Countries

Iran

Central Contacts

Hamideh Faculty member, Assistant Professor

Role: CONTACT

sabbaghi.opt@gmail.com

989120285930

Facility Contacts

Hamideh Sabbaghi

Role: primary

sabbaghi.opt@gmail.com

989120285930

Other Identifiers

IR.SBMU.RETECH.REC.1402.438

Identifier Type: -

Identifier Source: org_study_id