Status:
RECRUITING
AR Training Versus Patching in Unilateral Amblyopia
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Collaborating Sponsors:
First Affiliated Hospital of Fujian Medical University
Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Amblyopia Unilateral
Eligibility:
All Genders
5-55 years
Phase:
NA
Brief 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 impro...
Detailed Description
Poor compliance, limited improvement of visual functions, and regression after recovery of visual acuity have been observed in the management of amblyopia using conventional patching. Recently, dichop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06498206
Start Date
August 31 2024
End Date
December 1 2025
Last Update
April 10 2025
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, China