Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children
Recruiting now · Not applicable
Conditions studied: Ectopia Lentis, Lens Subluxation or Dislocation
In brief
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.
Key facts
- Study ID
- NCT07096622
- Run by
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- People needed
- 82
- Starts
- 2026-06-01
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-04-27
Who can join
Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Presence of diplopia in either eye;
- 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.).
Where it is running
- Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangzhou, Guangdong — Guangzhou, Guangdong, China (enrolling)
- Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital) — Qingyuan, Guangdong, China
Full record on ClinicalTrials.gov
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