Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Le… (NCT07096622) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children
China82 participantsStarted 2026-06-01
Plain-language summary
This is a multi-centre, open-label, parallel-group randomized controlled trial with the following objectives: Firstly, the investigators aim to evaluate the efficacy of web-based visual and perceptual training therapy on visual function in children with postoperative congenital ectopia lentis. Secondly, the investigators target to investigate the in stereoacuity, quality of life scores, and treatment compliance following visual and perceptual training intervention. Thirdly, to explore the safety profile of visual and perceptual training therapy software in this specific patient population. Lastly, this study aims to provide evidence-based recommendations for visual rehabilitation training strategies in children with postoperative congenital ectopia lentis in the Chinese population.
Who can participate
Age range4 Years – 12 Years
SexALL
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Inclusion criteria
✓. Aged 4-12 years, with no gender restriction;
✓. Diagnosed with congenital ectopia lentis;
✓. Underwent bilateral lensectomy combined with IOL scleral fixation, and within 1 month ± 1 week after the second-eye surgery;
✓. Best-corrected visual acuity (BCVA) of unilateral or bilateral eyes is no worse than 20/200 but below the normal level for the corresponding age: for 4-year-old children, BCVA ≤ 20/40; for children aged 5 years and above, BCVA ≤ 20/30;
✓. Written informed consent signed by the patient and their parents or legal guardians.
Exclusion criteria
✕. History of ocular trauma or previous ocular surgery other than the study-related procedure;
✕. Unable to cooperate with treatment, examinations, and follow-up assessments;
✕. Complicated with recurrent lens dislocation, severe cataract (dense, axial, opacity diameter \>3 mm and affecting central vision), secondary glaucoma, corneal endothelial decompensation, retinal detachment, or other conditions requiring urgent surgical intervention;
What they're measuring
1
Change in BCVA relative to baseline in study eyes
Timeframe: From start of intervention to the end of intervention at 3 months
Trial details
NCT IDNCT07096622
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
✕. Known history of neurological disorders (e.g., photosensitive epilepsy);
✕. Participation in other clinical trials within the postoperative period that may affect the outcomes of the present study;
✕. Use of topical or systemic medications that may cause visual impairment, or other vision therapies other than refractive correction in the past 3 months (e.g., atropine penalization, occlusion therapy, digital therapy, Bangerter filters, optical suppression, VR training, etc.).