Comparing augmented reality training to patching for treating amblyopia

Dichoptic Augmented Reality (AR) Training Versus Patching for Unilateral Amblyopia in Children and Adults

This study is testing whether augmented reality training can help people with lazy eye see better than the traditional method of patching.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 5 Years to 55 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06498206 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 5 to 55 years with unilateral amblyopia and specific visual acuity criteria.

Not a fit: Patients with organic eye diseases or brain lesions that hinder good vision will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment options for patients with amblyopia, improving their visual outcomes.

How similar studies have performed: While traditional patching has been widely used, this study explores a novel approach with augmented reality, which has not been extensively tested in this context.

Eligibility criteria

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 this trial is running

Shanghai

• Eye & ENT Hospital of Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Wen Wen, MD, PhD

Conditions: Amblyopia Unilateral, Augmented reality training, Dichoptic therapy, Patching