NCT06498206 AR Training Versus Patching in Unilateral Amblyopia
| NCT ID | NCT06498206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Amblyopia Unilateral |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2024-08-31 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2024-08-31 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06498206 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 55 Years, studying Amblyopia Unilateral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06498206 currently recruiting?
Yes, NCT06498206 is actively recruiting participants. Contact the research team at wenweneye@126.com for enrollment information.
Where is the NCT06498206 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06498206 clinical trial?
NCT06498206 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 114 participants.