Augmented Reality Training for Amblyopia After Congenital Cataract Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children.
Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Participants will be randomly assigned to one of two groups. One group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The other group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.
The main outcome is the change in best-corrected visual acuity of the amblyopic eye after 4 months of treatment. The study will also evaluate contrast sensitivity, binocular visual function, stereoacuity, vision-related symptoms, quality of life, and adverse events.
Eligibility criteria
Qualifiers
Aged 5 to 12 years, male or female.
Diagnosed with unilateral amblyopia after congenital cataract surgery.
Best-corrected visual acuity (BCVA) of the amblyopic eye ≤0.80 logMAR, BCVA of the fellow eye better than 0.15 logMAR, and interocular BCVA difference ≥0.20 logMAR.
Underwent cataract extraction at age ≤5 years and has stable ocular status at least 2 months after intraocular lens implantation.
Disqualifiers
Childhood cataract caused by causes other than congenital cataract, including traumatic, drug-induced, steroid-related, secondary, or metabolic cataract.
Other ocular organic diseases that may affect visual acuity assessment or amblyopia treatment evaluation, including but not limited to significant ptosis, corneal or other media opacity, glaucoma or persistent ocular hypertension, optic nerve disease, retinal disease, or cortical visual impairment.
Uncontrolled or clinically unstable severe systemic disease that may affect study safety, adherence, or outcome assessment, including active malignancy, severe cardiovascular disease, uncontrolled hypertension, epilepsy, or history of photosensitive epilepsy.
Implanted electronic medical devices that may be affected by the study device or may affect safe use of the device, such as a pacemaker or implantable cardioverter-defibrillator.
Trial design
Treatments tested in this trial
- Augmented Reality Amblyopia Training
- Conventional Patching
Treatment groups
88 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
Shenzhen Eye Hospital
Collaborator
Zhengzhou Second Hospital
Collaborator
Source ClinicalTrials.gov