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AmblyopiaNCT07622576

A Comparative Study of the Efficacy of AR Based Amblyopia Training Therapy and Occlusion Therapy in Older Children and Adults With Amblyopia

A study testing Augmented Reality glasses and Eye patch in people with Amblyopia and Amblyopia Unilateral, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to investigate the efficacy and safety of dichoptic treatment based on Augmented Reality (AR) technology in treating monocular amblyopia aged 12 to 55 years, and compare dichoptic AR treatment with the standard patching therapy. Read more about this study

Who is it for?
Ages 12 to 55 years
Conditions the study is for
Amblyopia, Amblyopia Unilateral
What is being tested?
Augmented Reality glasses and Eye patch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jun 2026to 31 May 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 12 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Individuals aged 12 to 55 years (12 ≤ age ≤ 55 years). Written informed consent shall be obtained from participants aged 18 years and above, or their legal guardians for those aged 12 to 17 years.
  • Unilateral amblyopia with the following criteria: the best-corrected visual acuity (BCVA) of the dominant eye ≥ 0.8, and an interocular BCVA difference of two or more lines. Participants shall have confirmed amblyopia with relevant risk factors and no organic ocular diseases.
  • For Individuals with refractive errors: the spherical equivalent (SE) measured via cycloplegic autorefraction or phoropter refraction ≤ -6.00 D. All participants shall have received optical refractive correction for more than 3 months, with stable visual acuity (acuity change < 1 line) within the latest 2 months.
  • Individuals with orthotropic eye position, including patients with strabismic amblyopia after strabismus correction. The distance manifest deviation measured at 6 m using the prism and alternate cover test shall be within 5 prism diopters (△).
  • Individuals who are willing to enroll in this study and are able to complete the entire trial protocol.

Who cannot join

  • Participants with other organic ocular disorders, including media opacities, nystagmus, eccentric fixation, acute inflammatory conditions such as keratitis, optic neuropathy, including glaucoma, retinal lesions, and cortical visual impairment.
  • Individuals diagnosed with tumors, cardiac diseases, hypertension, or epilepsy.
  • Individuals with implanted electronic devices such as cardiac pacemakers.
  • Individuals presenting with severe ocular inflammation, photophobia, or lacrimation in either eye.
  • Individuals with a history of ocular surgery that affects visual function, excluding congenital cataract extraction combined with intraocular lens implantation, strabismus correction and blepharoptosis repair.
  • Individuals with severe mental disorders or poor treatment adherence.
Show all 12Show fewer
  • Individuals currently using or planning to use medications that may affect visual function (mydriatic eye drops for refraction examination such as atropine are excluded).
  • Individuals with diplopia or inability to achieve binocular fusion during augmented reality-based amblyopia training.
  • Individuals who received any amblyopia treatments except spectacle lenses within 2 weeks prior to screening.
  • Individuals who enrolled in other clinical drug trials within 3 months or other medical device trials within 1 month before recruitment.
  • Individuals who are unable to attend regular ophthalmological examinations.
  • Individuals deemed ineligible by the investigators.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiajing Tang, M.D. contact

+86 13732227517

xiajingtang@zju.edu.cn

China1 site
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China 2nd Affiliated Hospital, School of Medicine

    Hangzhou, Zhejiang, 310000

    18757755101, ling.gong@zju.edu.cn

Other trials in China

About this study

The goal of this clinical trial is to investigate the efficacy and safety of dichoptic treatment based on Augmented Reality (AR) technology in treating monocular amblyopia aged 12 to 55 years, and compare dichoptic AR treatment with the standard patching therapy. The main questions it aims to answer are:

Does dichoptic AR treatment safely and effectively improve visual acuity and other monocular/binocular visual functions in older children and adults with amblyopia? Is binocular therapy superior to occlusion therapy?

Read the detailed description

Amblyopia is the most prevalent developmental visual disorder in children, characterized by a reduction in best-corrected visual acuity in one or both eyes that cannot be attributed to optical anomalies or organic ocular pathologies. Epidemiological investigations have demonstrated that the prevalence of amblyopia among children ranges from 3% to 6%, rendering it one of the leading causes of unilateral visual impairment in pediatric populations. Beyond reduced visual acuity, amblyopia may also induce deficits in stereopsis, oculomotor coordination, and cognitive function, which substantially compromise patients' daily activities. Current mainstream clinical interventions for amblyopia primarily include refractive correction, occlusion therapy, penalization therapy, and visual function training.

Given the existence of a critical period for the development of the visual cortex in children, the treatment of amblyopia is constrained by a distinct therapeutic time window. Earlier intervention yields a higher probability of visual acuity recovery. Conversely, patients treated beyond the critical period of visual development generally exhibit a poor response to conventional therapies. Accordingly, amblyopia in older children and adults remains a major clinical challenge. With advancing research on the binocular pathogenesis of amblyopia-such as binocular imbalance induced by binocular contrast gain control and impairment of the parvocellular visual pathway originating from the lateral geniculate nucleus (LGN)-novel therapeutic strategies for amblyopia have been continuously developed.

Visual perceptual learning, which involves repeated training on near-threshold visual tasks to strengthen relevant neural pathways and elicit long-term improvements in visual function, has achieved favorable clinical outcomes in amblyopic patients. Since this approach can facilitate cortical plasticity, adult amblyopes who fail to respond to conventional treatments also show marked therapeutic responses. In recent years, dichoptic training, which delivers distinct visual stimuli to each eye simultaneously to promote binocular coordination and rehabilitate the parvocellular pathway, has exhibited promising efficacy in ameliorating monocular and binocular visual functions and shortening treatment duration in amblyopic patients.

Augmented Reality (AR) has attracted considerable attention due to its immersive interactive properties. By superimposing virtual visual stimuli onto the real-world environment, AR provides an innovative modality for amblyopia management. Compared with traditional therapies, AR systems enable real-time modulation of stimulus parameters (e.g., spatial frequency, contrast, and binocular balance), thereby supporting personalized and precise treatment. Preliminary studies have verified that AR-based training can significantly enhance contrast sensitivity and stereoscopic vision in adult amblyopes. Additionally, the gamified design of visual tasks remarkably improves patient adherence to treatment.

Nevertheless, existing studies on AR-based amblyopia training are mostly confined to laboratory settings or short-term interventions. Large-scale real-world evidence is still lacking to validate its long-term safety and general applicability. Furthermore, the assessment of visual function improvements after treatment mainly relies on visual acuity measurements, which represents a limited evaluation framework; comprehensive and systematic assessment systems remain underdeveloped.

In addition, amblyopia in individuals over 12 years of age (older children and adults) constitutes a difficult-to-treat cohort in clinical practice. These patients present low cortical plasticity and poor responses to occlusion therapy. Although dichoptic training is capable of inducing cortical plasticity, systematic real-world studies on this intervention are still insufficient. Therefore, the present study conducted in routine clinical settings targeting this specific population not only possesses important clinical implications, but also provides theoretical and practical evidence for the establishment of novel therapeutic regimens for amblyopia.

Being tested
Augmented Reality glasses, Eye patch
Keywords
Amblyopia, Dichopitc treatment, Binocular treatment, Patching, Occlusion
Medical subject headings
Amblyopia, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented Reality glassesDevice

    Dichoptic Augmented Reality (AR) treatment uses the smart glasses connected to a video playback device, and participants watch cartoons, movies, or daily videos during training. The system performs real-time dichoptic processing on visual contents: high spatial frequency images are presented to the amblyopic eye, while low-contrast images are delivered to the dominant eye.

  • Eye patchDevice

    Opaque eye patches were used to cover the fellow eye (dominant eye), forcing participants to view objects with their amblyopic eye. The total daily occlusion duration was 4 hours, which could be split into separate sessions with a minimum duration of 2 hours per session. The intervention lasted for 3 months in total.

Study groups in NCT07622576
Study groupRoleWhat they receive
Dichoptic treatmentExperimentalThe AR smart glasses are connected to a video playback device, and participants watch cartoons, movies, or daily videos during training. The system performs real-time dichoptic processing on visual contents: high spatial frequency images are presented to the amblyopic eye, while low-contrast images are delivered to the dominant eye. The scheduled daily training duration is 1.5 hours, which can be divided into multiple sessions with a minimum single-session duration of 30 minutes. The total intervention period lasts for 3 months.
Receives: Device: Augmented Reality glasses
PatchingOtherOpaque eye patches were used to cover the fellow eye (dominant eye), forcing participants to view objects with their amblyopic eye. The total daily occlusion duration was 4 hours, which could be split into separate sessions with a minimum duration of 2 hours per session. The intervention lasted for 3 months in total.
Receives: Device: Eye patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Corrected Visual Acuity

    BCVA was measured with optimal refractive correction (if needed) and without cycloplegia, using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (3)
  1. Stereoacuity

    Stereoacuity was measured by the RandomDot test and a disparity detection task.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Binocular balance

    Binocular balance point is measured by binocular orientation task.

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Contrast sensitivity function

    Contrast sensitivity function is measured by the contrast sensitivity detection task at different spatial frequencies.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622576
Sponsor's protocol ID
2026-0200
Status last verified
May 2026
First submitted
28 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Reality glasses and Eye patch in people with Amblyopia and Amblyopia Unilateral, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 12 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 3 Jun 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 Xiajing Tang, M.D. (+86 13732227517, xiajingtang@zju.edu.cn), 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: From enrollment to the end of treatment at 12 weeks). 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 3 Jun 2026.

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