AR Training Versus Patching in Unilateral Amblyopia
Dichoptic Augmented Reality (AR) Training Versus Patching for Unilateral Amblyopia in Children and Adults
Eye & ENT Hospital of Fudan University
114 participants
Aug 31, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Aged 5-55 years (including 5 years and 55 years);
- 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;
- Patients have applied optical refractive correction for more than 3 months;
- Ability attend visits and complete the treatment;
- 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 Criteria10
- 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);
- Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment);
- Implantable electronic device;
- A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair);
- A history of ocular trauma affecting vision;
- Receiving amblyopia therapy (except wearing glasses) within 2 weeks prior to presentation;
- History of epilepsy or mental illness, or cognitive defects;
- Currently taking medications or needing to take medications during the study period that may affect vision;
- Inability to comply with the treatments or follow-up visits required;
- 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.
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Interventions
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.
Conventional patching therapy.
Locations(1)
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NCT06498206