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?
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 (△).
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.
Parallel
Augmented Reality glasses
DeviceDichoptic 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 patch
DeviceOpaque 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.
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.
Stereoacuity
Stereoacuity was measured by the RandomDot test and a disparity detection task.
Binocular balance
Binocular balance point is measured by binocular orientation task.
Contrast sensitivity function
Contrast sensitivity function is measured by the contrast sensitivity detection task at different spatial frequencies.
Adverse events
Adverse events captured by an administering protocol-defined questionnaire regarding their symptoms and diplopia
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.
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