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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Wen Wen, MD, PhD
wenweneye@126.com
86+(021)34233133
Backup
Yulian Zhou, MD
zyl_1208@163.com
Time Frame
Start Date: 2024-08-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 114
Treatments
Experimental: AR training group
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.
Active_comparator: Patching group
Conventional patching therapy.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Jiangsu Provincial People's Hospital, First Affiliated Hospital of Fujian Medical University
Leads: Eye & ENT Hospital of Fudan University

This content was sourced from clinicaltrials.gov