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Not yet recruitingNCT07622576Updated Jun 3, 2026

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

An interventional study of Augmented Reality glasses and Eye patch in Amblyopia and Amblyopia Unilateral, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Amblyopia
  • Amblyopia Unilateral

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Keywords

  • Amblyopia
  • Dichopitc treatment
  • Binocular treatment
  • Patching
  • Occlusion
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals aged 12 to 55 years (12 ≤ age ≤ 55 years). Written shall be obtained from participants aged 18 years and above, or their legal guardians for those aged 12 to 17 years.
  2. 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.
  3. 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.
  4. 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 (△).
  5. Individuals who are willing to enroll in this study and are able to complete the entire trial protocol.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Individuals diagnosed with tumors, cardiac diseases, hypertension, or epilepsy.
  3. Individuals with implanted electronic devices such as cardiac pacemakers.
  4. Individuals presenting with severe ocular inflammation, photophobia, or lacrimation in either eye.
  5. 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.
  6. Individuals with severe mental disorders or poor treatment adherence.
  7. Individuals currently using or planning to use medications that may affect visual function (mydriatic eye drops for refraction examination such as atropine are excluded).
  8. Individuals with diplopia or inability to achieve binocular fusion during augmented reality-based amblyopia training.
  9. Individuals who received any amblyopia treatments except spectacle lenses within 2 weeks prior to screening.
  10. Individuals who enrolled in other clinical drug trials within 3 months or other medical device trials within 1 month before recruitment.
  11. Individuals who are unable to attend regular ophthalmological examinations.
  12. Individuals deemed ineligible by the investigators.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Dichoptic treatment

    The 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.

    Device: Augmented Reality glasses

  • Other
    Patching

    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.

    Device: Eye patch

Interventions

  • DeviceAugmented Reality glasses

    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.

  • DeviceEye patch

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  1. Stereoacuity

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

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Binocular balance

    Binocular balance point is measured by binocular orientation task.

    Time frame: 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

Other outcomes

  1. Adverse events

    Adverse events captured by an administering protocol-defined questionnaire regarding their symptoms and diplopia

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Adherence

    The percentage of prescribed treatment completed (adherence) is computed using the ratio of the completed and prescribed hours of treatment. The completed treatment duration is recorded by the devices (dichoptic treatment) or self-reported calendars.

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 site
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China 2nd Affiliated Hospital, School of Medicine
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07622576
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Xiajing Tang, M.D.
Contact
xiajingtang@zju.edu.cn
+86 13732227517

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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