AmblyopiaNCT07709832
A Randomized Controlled Trial of Autostereoscopic 3D Vision Therapy for Amblyopia
A study testing Autostereoscopic 3D Training and Conventional Patching in people with Amblyopia and Visual Training, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Amblyopia, Visual Training, Visual Functions
- What is being tested?
- Autostereoscopic 3D Training and Conventional Patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 31 Jul 2027
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral amblyopia (anisometropic, strabismic, or ametropic)
- Age: 7 to 12 years
- Amblyopic eye BCVA: 0.1 to 0.8 LogMAR
- Fellow eye BCVA: ≥ 0.8 LogMAR
- Stable refractive status (≤ ±0.50D change in past 6 months)
- Written informed consent from participant and guardian
Who cannot join
- Deprivation amblyopia (congenital cataract, ptosis, etc.)
- Organic ocular disease (glaucoma, retinopathy, optic neuropathy)
- Previous ocular surgery or trauma
- Severe dry eye or other ocular surface disorders
- Uncontrolled systemic diseases (diabetes, hypertension)
- Neuropsychiatric conditions preventing cooperation
- Participation in other clinical trials within 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Hospital
Beijing
Jin Yuan, 010-58366699, yuanjincornea@126.com
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy and Safety of an Autostereoscopic 3D Vision Therapy System for Visual Function Rehabilitation in Children With Unilateral Amblyopia
The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. The main questions it aims to answer are:
- Does autostereoscopic 3D vision training improve best corrected visual acuity in the amblyopic eye compared to conventional patching therapy?
- What side effects or discomfort do participants experience during 3D training versus patching? Researchers will compare the autostereoscopic 3D training system to conventional daily eye patching to see which treatment works better for improving vision in amblyopia.
Read more
Participants will:
- Be randomly assigned to either the 3D training group or the patching group
- Complete daily home treatment for 6 months - either 20 minutes of 3D vision training or 2 hours of continuous eye patching
- Visit the clinic at baseline, 1 month, 3 months, and 6 months for eye exams and vision tests
- Have their treatment progress monitored remotely through training data logs or patching diaries
- Conditions
- Amblyopia, Visual Training, Visual Functions, Visual Health
- Being tested
- Autostereoscopic 3D Training, Conventional Patching
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autostereoscopic 3D TrainingDevice
Daily 20-minute autostereoscopic 3D amblyopia training session, 5+ days per week for 6 months. Training consists of 15 minutes of monocular perceptual learning with Gabor patches (adaptive difficulty algorithm) and 5 minutes of binocular vergence training. Home-based training with remote data monitoring.
Conventional PatchingDevice
Daily continuous 2-hour occlusion of the non-amblyopic eye using medical adhesive eye patches, 5+ days per week for 6 months. Patients are encouraged to perform near visual activities (reading, writing, puzzles) during patching to enhance amblyopic eye stimulation. Parent-supervised home therapy with daily patching logs.
| Study group | Role | What they receive |
|---|---|---|
| Autostereoscopic 3D Training Group | Experimental | Not described Receives: Device: Autostereoscopic 3D Training |
| Conventional Patching Group | Active comparator | Not described Receives: Device: Conventional Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
Measured: baseline to 6 months
Secondary outcomes (7)
Distance Stereoacuity
Measured: baseline to 6 months
Near Stereoacuity
Measured: Baseline to 6 months
Contrast Sensitivity Function
Measured: Baseline to 6 months
Computer Vision Syndrome Questionnaire (CVS-Q) Score
Measured: Baseline to 6 months
Simulator Sickness Questionnaire (SSQ) Score
Measured: Baseline to 6 months
Adherence
Measured: Baseline to 6 months
Intraocular Pressure (IOP)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (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.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyuan,MD, Beijing Tongren Hospital
- Investigators
- Jin Yuan, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709832
- Sponsor's protocol ID
- TREC2025-KY194
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy and Safety of an Autostereoscopic 3D Vision Therapy System for Visual Function Rehabilitation in Children With Unilateral Amblyopia
- ClinicalTrials.gov ID
- NCT07709832
- Acronym / sponsor ID
- TREC2025-KY194
- Conditions
- Amblyopia, Visual Training, Visual Functions, Visual Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Jul 2026 (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.
The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. The main questions it aims to answer are:
- Does autostereoscopic 3D vision training improve best corrected visual acuity in the amblyopic eye compared to conventional patching therapy?
- What side effects or discomfort do participants experience during 3D training versus patching? Researchers will compare the autostereoscopic 3D training system to conventional daily eye patching to see which treatment works better for improving vision in amblyopia.
Participants will:
- Be randomly assigned to either the 3D training group or the patching group
- Complete daily home treatment for 6 months - either 20 minutes of 3D vision training or 2 hours of continuous eye patching
- Visit the clinic at baseline, 1 month, 3 months, and 6 months for eye exams and vision tests
- Have their treatment progress monitored remotely through training data logs or patching diaries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autostereoscopic 3D Training Group | Experimental | Device: Autostereoscopic 3D Training |
| Conventional Patching Group | Active comparator | Device: Conventional Patching |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Unilateral amblyopia (anisometropic, strabismic, or ametropic)
- Age: 7 to 12 years
- Amblyopic eye BCVA: 0.1 to 0.8 LogMAR
- Fellow eye BCVA: ≥ 0.8 LogMAR
- Stable refractive status (≤ ±0.50D change in past 6 months)
Key exclusion criteria (7 listed)
- Deprivation amblyopia (congenital cataract, ptosis, etc.)
- Organic ocular disease (glaucoma, retinopathy, optic neuropathy)
- Previous ocular surgery or trauma
- Severe dry eye or other ocular surface disorders
- Uncontrolled systemic diseases (diabetes, hypertension)
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 |
|---|---|---|
| Autostereoscopic 3D TrainingDaily 20-minute autostereoscopic 3D amblyopia training session, 5+ days per week for 6 months. Training consists of 15 minutes of monocular perceptual learning with Gabor patches (adaptive difficulty algorithm) and 5 minutes of binocular vergence training. Home-based training with remote data monitoring. | Device | Autostereoscopic 3D Training Group |
| Conventional PatchingDaily continuous 2-hour occlusion of the non-amblyopic eye using medical adhesive eye patches, 5+ days per week for 6 months. Patients are encouraged to perform near visual activities (reading, writing, puzzles) during patching to enhance amblyopic eye stimulation. Parent-supervised home therapy with daily patching logs. | Device | Conventional Patching Group |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: baseline to 6 months
7 secondary outcomes
Distance Stereoacuity
Time frame: baseline to 6 months
Near Stereoacuity
Time frame: Baseline to 6 months
Contrast Sensitivity Function
Time frame: Baseline to 6 months
Computer Vision Syndrome Questionnaire (CVS-Q) Score
Time frame: Baseline to 6 months
Simulator Sickness Questionnaire (SSQ) Score
Time frame: Baseline to 6 months
Adherence
Time frame: Baseline to 6 months
Intraocular Pressure (IOP)
Time frame: Baseline to 6 months
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 17 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jin Yuan principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autostereoscopic 3D Training and Conventional Patching in people with Amblyopia and Visual Training, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. 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 17 Jul 2026. 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 China. 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. 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 Jin Yuan (010-58366699, yuanjincornea@126.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 (BCVA) (time frame: baseline to 6 months). 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 17 Jul 2026.