💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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