AmblyopiaNCT07103473
Interactive Binocular Treatment (I- BiT) in Adult Patients With Anisometropic Amblyopia
A study testing Interactive Binocular Treatment in people with Amblyopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Interactive Binocular Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIran
- Study dates
- 10 Dec 2025to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
- Age range from 18 to 40 years
- Best corrected visual acuity of 0.3 log units or worse in one eye
- Cases of mild and moderate anisometropic amblyopia (BCVA≤0.3)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Hamideh Sabbaghi
Tehran, Tehran Province, 16666
Hamideh Sabbaghi, 989120285930, sabbaghi.opt@gmail.com
About this study
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
- Being tested
- Interactive Binocular Treatment
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Binocular TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Binocular Treatment | Active comparator | Patients in this arm will receive the Interactive Binocular Treatment therapy as an intervention Receives: Device: Interactive Binocular Treatment |
| Placebo | Placebo comparator | Patients in this arm will receive no active treatment Receives: Device: Interactive Binocular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
The changes of the best corrected visual acuity after one month therapy will be measured as the primary outcome measure.
Measured: one month
Secondary outcomes (1)
Stereopsis
The changes of stereopsis will be assessed after one month therapy.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start10 Dec 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103473
- Sponsor's protocol ID
- IR.SBMU.RETECH.REC.1402.438
- Status last verified
- Aug 2025
- First submitted
- 27 Oct 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Binocular Treatment (I- BiT) in Adult Patients With Anisometropic Amblyopia
- ClinicalTrials.gov ID
- NCT07103473
- Acronym / sponsor ID
- IR.SBMU.RETECH.REC.1402.438
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Binocular Treatment | Active comparator | Device: Interactive Binocular TreatmentPatients in this arm will receive the Interactive Binocular Treatment therapy as an intervention |
| Placebo | Placebo comparator | Device: Interactive Binocular TreatmentPatients in this arm will receive no active treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Binocular TreatmentPatients 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. | Device | Interactive Binocular Treatment, Placebo |
Primary outcome
Best corrected visual acuity
Time frame: one month
The changes of the best corrected visual acuity after one month therapy will be measured as the primary outcome measure.
1 secondary outcome
Stereopsis
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
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Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
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OCT Eccentric Fixation and Amblyopia in Children
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Non-invasive Induction of Metaplasticity for Amblyopia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Binocular Treatment in people with Amblyopia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamideh Faculty member, Assistant Professor (989120285930, sabbaghi.opt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.