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Active, not recruiting Not applicable

AR Training in Adults With Unilateral Amblyopia

NCT06704737 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-02-25
Last updated
2024-11-26

Condition(s) studied

Amblyopia UnilateralAmblyopia Functional

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 adults with unilateral amblyopia

Patching: Conventional patching therapy.

Study summary

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

Specific Aim 2 (Secondary): To compare the changes of visual functions and pathway selective neural activity in the early visual and cortex subcortical nuclei including the lateral geniculate nucleus between AR training and patching for the treatment of adults with unilateral amblyopia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18-50 years (including 18 years and 50 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 with deprivation amblyopia should have relieved the deprivation factors such as opacification of the ocular media (e.g. cataract, nonclearing vitreous opacity, corneal opacities) or other occlusion of the visual axis (e.g. blepharoptosis). 4. Normal binocular alignment including strabismic amblyopia with orthotropia after optical refractive correction or surgical correction, or intermittent exotropia within a range of -15 to 0 prism diopters measured by the prism cover test. 5. Patients should have been applyng optical refractive correction for more than 3 months before enrollment. 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. A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair); 4. A history of ocular trauma affecting vision; 5. Receiving amblyopia therapy (except wearing refractive correction glasses) within 2 weeks before enrollment; 6. History of epilepsy or mental illness, or cognitive defects; 7. Currently taking medications or needing to take medications during the study period that may affect vision; 8. Contraindications to magnetic resonance imaging such as implantable electronic device, metal implants (e.g. metal dentures, craniofacial titanium plates), claustrophobia and pregnancy.

Primary outcome measure(s)

  • Change in visual acuity at far — 1 week, 1month, 3month, 6month
    Best-corrected visual acuity in the amblyopic eye measured at the distance of 2.5 meters using standardized logMAR visual charts.

Trial sites (1)

FacilityCityRegionStatus
Eye & ENT Hospital of Fudan University Shanghai China
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 NCT06704737 on ClinicalTrials.gov ↗ ← All trials in China