Deprivation AmblyopiaNCT07693790
Augmented Reality Training for Amblyopia After Congenital Cataract Surgery
A study testing Augmented Reality Amblyopia Training and Conventional Patching in people with Deprivation Amblyopia and Congenital Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children. Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Deprivation Amblyopia, Congenital Cataract
- What is being tested?
- Augmented Reality Amblyopia Training and Conventional Patching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to Jan 2028
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5 to 12 years, male or female.
- Diagnosed with unilateral amblyopia after congenital cataract surgery.
- Best-corrected visual acuity (BCVA) of the amblyopic eye ≤0.80 logMAR, BCVA of the fellow eye better than 0.15 logMAR, and interocular BCVA difference ≥0.20 logMAR.
- Underwent cataract extraction at age ≤5 years and has stable ocular status at least 2 months after intraocular lens implantation.
- If refractive error is present, optical correction has been worn for at least 3 months.
- Orthophoria, or if strabismus is present, manifest deviation at distance of 6 m is ≤4 prism diopters after strabismus correction as measured by prism cover test.
- Able to understand the study procedures, and written informed consent is obtained from the participant and/or legal guardian as required.
Who cannot join
- Childhood cataract caused by causes other than congenital cataract, including traumatic, drug-induced, steroid-related, secondary, or metabolic cataract.
- Other ocular organic diseases that may affect visual acuity assessment or amblyopia treatment evaluation, including but not limited to significant ptosis, corneal or other media opacity, glaucoma or persistent ocular hypertension, optic nerve disease, retinal disease, or cortical visual impairment.
- Uncontrolled or clinically unstable severe systemic disease that may affect study safety, adherence, or outcome assessment, including active malignancy, severe cardiovascular disease, uncontrolled hypertension, epilepsy, or history of photosensitive epilepsy.
- Implanted electronic medical devices that may be affected by the study device or may affect safe use of the device, such as a pacemaker or implantable cardioverter-defibrillator.
- Significant ocular inflammation, photophobia, tearing, eye pain, or other ocular surface or anterior segment disease at screening that may affect visual acuity testing, device wearing, or completion of training.
- Obvious dizziness, motion sickness, acrophobia, balance disorder, or sequelae of previous brain injury that may affect safe wearing of the augmented reality device or training adherence.
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- Facial trauma, craniofacial deformity, or head and facial structural abnormality that may affect normal wearing, positioning, or safe use of the augmented reality device.
- Severe psychiatric, cognitive, developmental, or behavioral disorder that may prevent understanding of study procedures, completion of training, or follow-up.
- Current or planned use of medications that may affect visual acuity, refractive status, pupil status, or visual function assessment, except for short-term cycloplegic agents used for routine ophthalmic examination.
- Unable to simultaneously perceive binocular stimuli in the device or unable to complete binocular simultaneous vision training after device screening or calibration.
- Received amblyopia treatment other than spectacle correction within 2 weeks before screening, including patching, atropine penalization, visual training, binocular vision training, or other amblyopia-related interventions.
- Participation in another drug clinical trial within 3 months or another medical device clinical trial within 1 month before screening.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness and Safety of Augmented Reality-Based Amblyopia Training for Postoperative Congenital Cataract Patients: A Multicenter, Superiority, Randomized, Parallel-Controlled Trial Protocol
This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children.
Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Participants will be randomly assigned to one of two groups. One group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The other group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.
The main outcome is the change in best-corrected visual acuity of the amblyopic eye after 4 months of treatment. The study will also evaluate contrast sensitivity, binocular visual function, stereoacuity, vision-related symptoms, quality of life, and adverse events.
Read the detailed description
This is a multicenter, randomized, parallel-group, superiority clinical trial designed to evaluate the efficacy and safety of augmented reality training for children with unilateral amblyopia after congenital cataract surgery.
The study plans to enroll 88 participants aged 5 to 12 years who have unilateral amblyopia after congenital cataract surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. The experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.
The study includes a screening period, a baseline visit, and follow-up visits after 1 month and 4 months of treatment. The primary outcome is the change from baseline in best-corrected visual acuity of the amblyopic eye, measured in logMAR units, at 4 months. Secondary outcomes include contrast sensitivity, suppression status, stereoacuity, and quality of life assessed using the Chinese version of the PedsQL 4.0 Generic Core Scales. Safety outcomes include computer vision symptoms assessed using the CVSS-6 scale and the incidence of adverse events, including dizziness, headache, eye fatigue, blurred vision, and skin allergy.
The purpose of this trial is to determine whether augmented reality amblyopia training provides superior improvement in visual acuity compared with conventional patching, while also assessing its effects on binocular visual function and treatment safety in this patient population.
- Conditions
- Deprivation Amblyopia, Congenital Cataract
- Being tested
- Augmented Reality Amblyopia Training, Conventional Patching
- Keywords
- Amblyopia, Augmented Reality
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Amblyopia TrainingDevice
Participants assigned to the experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will present visual training tasks and record training duration, task completion, and adherence data.
Conventional PatchingBehavioural
Participants assigned to the control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Amblyopia Training | Experimental | Participants in this arm will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will record training duration, task completion, and adherence data. Receives: Device: Augmented Reality Amblyopia Training |
| Conventional Patching | Active comparator | Participants in this arm will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits. Receives: Behavioral: Conventional Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 4 Months
Best-corrected visual acuity of the amblyopic eye will be measured using the ETDRS visual acuity chart and recorded in logMAR units. The primary outcome is defined as the change from baseline to 4 months, calculated as baseline logMAR BCVA minus 4-month logMAR BCVA. A larger positive value indicates greater visual acuity improvement.
Measured: Baseline, 4 months
Secondary outcomes (6)
Change From Baseline in Contrast Sensitivity at 1 Month and 4 Months
Contrast sensitivity will be measured using the CSV-1000 test at different spatial frequencies, including 3, 6, 12, and 18 cycles per degree. Changes from baseline to 1 month and 4 months will be evaluated.
Measured: Baseline, 4 months
Change From Baseline in Suppression Status at 1 Month and 4 Months
Suppression status will be assessed using the Bagolini striated glasses test and the Worth 4-dot test. The presence or absence of suppression and abnormal retinal correspondence will be recorded and compared across study visits.
Measured: Baseline, 4 months
Change From Baseline in Stereoacuity at 1 Month and 4 Months
Stereoacuity will be assessed using the Randot stereotest for distance and near stereoacuity and the Titmus stereotest for near stereoacuity. Improvement will be defined as an improvement of at least one stereoacuity level from baseline or a change from no measurable stereoacuity to measurable stereoacuity.
Measured: Baseline, 4 months
Change From Baseline in Quality of Life at 1 Month and 4 Months
Quality of life will be assessed using the Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales. The scale includes physical, emotional, social, and school functioning domains. Changes from baseline to 1 month and 4 months will be evaluated.
Measured: Baseline, 4 months
Change From Baseline in Computer Vision Symptoms at 1 Month and 4 Months
Computer vision symptoms will be assessed using the CVSS-6 scale. The scale evaluates symptoms including eye fatigue, blurred vision, dry eye sensation, burning or stinging sensation, increased tearing or discharge, and headache. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms.
Measured: Baseline, 4 months
Incidence of Adverse Events During the Study
Adverse events will be recorded throughout the study, including dizziness, headache, eye fatigue, blurred vision, skin allergy, and other discomforts. The incidence, severity, management, outcome, and relationship to the study intervention will be documented.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deprivation 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the augmented reality amblyopia training group or the conventional patching group. The two groups will receive their assigned interventions in parallel for 4 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Eye Hospital, Zhengzhou Second Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693790
- Sponsor's protocol ID
- SQIIT-2026-035
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Augmented Reality-Based Amblyopia Training for Postoperative Congenital Cataract Patients: A Multicenter, Superiority, Randomized, Parallel-Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07693790
- Acronym / sponsor ID
- SQIIT-2026-035
- Conditions
- Deprivation Amblyopia, Congenital Cataract
- Keywords
- Amblyopia, Augmented Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Eye Hospital, Zhengzhou Second Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 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.
This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children.
Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Participants will be randomly assigned to one of two groups. One group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The other group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.
The main outcome is the change in best-corrected visual acuity of the amblyopic eye after 4 months of treatment. The study will also evaluate contrast sensitivity, binocular visual function, stereoacuity, vision-related symptoms, quality of life, and adverse events.
Detailed description
This is a multicenter, randomized, parallel-group, superiority clinical trial designed to evaluate the efficacy and safety of augmented reality training for children with unilateral amblyopia after congenital cataract surgery.
The study plans to enroll 88 participants aged 5 to 12 years who have unilateral amblyopia after congenital cataract surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. The experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.
The study includes a screening period, a baseline visit, and follow-up visits after 1 month and 4 months of treatment. The primary outcome is the change from baseline in best-corrected visual acuity of the amblyopic eye, measured in logMAR units, at 4 months. Secondary outcomes include contrast sensitivity, suppression status, stereoacuity, and quality of life assessed using the Chinese version of the PedsQL 4.0 Generic Core Scales. Safety outcomes include computer vision symptoms assessed using the CVSS-6 scale and the incidence of adverse events, including dizziness, headache, eye fatigue, blurred vision, and skin allergy.
The purpose of this trial is to determine whether augmented reality amblyopia training provides superior improvement in visual acuity compared with conventional patching, while also assessing its effects on binocular visual function and treatment safety in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the augmented reality amblyopia training group or the conventional patching group. The two groups will receive their assigned interventions in parallel for 4 months.
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Amblyopia Training | Experimental | Device: Augmented Reality Amblyopia TrainingParticipants in this arm will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will record training duration, task completion, and adherence data. |
| Conventional Patching | Active comparator | Behavioral: Conventional PatchingParticipants in this arm will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 5 to 12 years, male or female.
- Diagnosed with unilateral amblyopia after congenital cataract surgery.
- Best-corrected visual acuity (BCVA) of the amblyopic eye ≤0.80 logMAR, BCVA of the fellow eye better than 0.15 logMAR, and interocular BCVA difference ≥0.20 logMAR.
- Underwent cataract extraction at age ≤5 years and has stable ocular status at least 2 months after intraocular lens implantation.
- If refractive error is present, optical correction has been worn for at least 3 months.
Key exclusion criteria (13 listed)
- Childhood cataract caused by causes other than congenital cataract, including traumatic, drug-induced, steroid-related, secondary, or metabolic cataract.
- Other ocular organic diseases that may affect visual acuity assessment or amblyopia treatment evaluation, including but not limited to significant ptosis, corneal or other media opacity, glaucoma or persistent ocular hypertension, optic nerve disease, retinal disease, or cortical visual impairment.
- Uncontrolled or clinically unstable severe systemic disease that may affect study safety, adherence, or outcome assessment, including active malignancy, severe cardiovascular disease, uncontrolled hypertension, epilepsy, or history of photosensitive epilepsy.
- Implanted electronic medical devices that may be affected by the study device or may affect safe use of the device, such as a pacemaker or implantable cardioverter-defibrillator.
- Significant ocular inflammation, photophobia, tearing, eye pain, or other ocular surface or anterior segment disease at screening that may affect visual acuity testing, device wearing, or completion of training.
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 |
|---|---|---|
| Augmented Reality Amblyopia TrainingParticipants assigned to the experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will present visual training tasks and record training duration, task completion, and adherence data. | Device | Augmented Reality Amblyopia Training |
| Conventional PatchingParticipants assigned to the control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits. | Behavioural | Conventional Patching |
Primary outcome
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 4 Months
Time frame: Baseline, 4 months
Best-corrected visual acuity of the amblyopic eye will be measured using the ETDRS visual acuity chart and recorded in logMAR units. The primary outcome is defined as the change from baseline to 4 months, calculated as baseline logMAR BCVA minus 4-month logMAR BCVA. A larger positive value indicates greater visual acuity improvement.
6 secondary outcomes
Change From Baseline in Contrast Sensitivity at 1 Month and 4 Months
Time frame: Baseline, 4 months
Change From Baseline in Suppression Status at 1 Month and 4 Months
Time frame: Baseline, 4 months
Change From Baseline in Stereoacuity at 1 Month and 4 Months
Time frame: Baseline, 4 months
Change From Baseline in Quality of Life at 1 Month and 4 Months
Time frame: Baseline, 4 months
Change From Baseline in Computer Vision Symptoms at 1 Month and 4 Months
Time frame: Baseline, 4 months
Incidence of Adverse Events During the Study
Time frame: 4 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 9 Jul 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Amblyopia Training and Conventional Patching in people with Deprivation Amblyopia and Congenital Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 7 inclusion and 13 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ruixin Wang (+86-20-87332702, wangruixin@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 4 Months (time frame: Baseline, 4 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 9 Jul 2026.