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Recruiting Not applicable

AR Training Versus Patching in Unilateral Amblyopia

NCT06498206 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-08-31
Last updated
2025-04-10

Condition(s) studied

Amblyopia Unilateral

Investigational drug(s) / intervention(s)

AR trainingPatching

AR training: Dichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in unilateral amblyopia.

Patching: Conventional patching therapy.

Study summary

This is a multi-center, randomized controlled trial to compare the effectiveness of AR training with patching for the treatment of unilateral amblyopia.

Specific Aim 1 (Primary): To compare the improvement of visual acuity in the amblyopic eye between AR training and patching for the treatment of unilateral amblyopia.

Specific Aim 2 (Secondary): To compare the improvement of visual functions between AR training and patching for the treatment of unilateral amblyopia.

Eligibility

Sex
ALL
Min age
5 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 5-55 years (including 5 years and 55 years); 2. Best-corrected visual acuity worse than 20/30 but no worse than 20/200 in the amblyopic eye, interocular difference of 2 or more lines, with the better eye within the normal range; 3. Patients have applied optical refractive correction for more than 3 months; 4. Ability attend visits and complete the treatment; 5. Normal binocular alignment including strabismic amblyopia with orthotropia after surgical correction, or intermittent exotropia within a range of -15 to 0 prism diopters measured by the prism cover test. Exclusion Criteria: 1. Organic eye diseases preventing the establishment of good vision (e.g. ptosis, media opacity, nystagmus, paracentral fixation, acute inflammation like keratitis, optic nerve diseases like glaucoma, retinal diseases); 2. Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment); 3. Implantable electronic device; 4. A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair); 5. A history of ocular trauma affecting vision; 6. Receiving amblyopia therapy (except wearing glasses) within 2 weeks prior to presentation; 7. History of epilepsy or mental illness, or cognitive defects; 8. Currently taking medications or needing to take medications during the study period that may affect vision; 9. Inability to comply with the treatments or follow-up visits required; 10. Participation in clinical trials on drugs within 3 months prior to presentation, or clinical trials on other medical devices within 30 days prior to presentation.

Primary outcome measure(s)

  • Total effective rate — 13 weeks
    The effective rate is defined as the proportion of patients whose best-corrected visual acuity (BCVA) at distance improved ≥0.2 LogMAR after treatment compared to the baseline. BCVA at distance is measured with ETDRS chart.

Trial sites (1)

FacilityCityRegionStatus
Eye & ENT Hospital of Fudan University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06498206 on ClinicalTrials.gov ↗ ← All trials in China