Comparing augmented reality training to patching for treating amblyopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized controlled trial aims to evaluate the effectiveness of augmented reality (AR) training compared to traditional patching in improving visual acuity and overall visual functions in patients with unilateral amblyopia. The study addresses common issues with patching, such as poor compliance and limited improvement, by utilizing innovative binocular therapy based on neural deficits associated with amblyopia. Participants aged 5 to 55 years with specific visual acuity criteria will be enrolled, and their progress will be monitored throughout the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Wen Wen, MD, PhD
• Email: wenweneye@126.com
• Phone: 86+(021)34233133

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.