Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2026-06-01
Last updated
2026-04-27
Condition(s) studied
Ectopia LentisLens Subluxation or Dislocation
Investigational drug(s) / intervention(s)
perceptual learning visual treatment,HVT
perceptual learning visual treatment,HVT: After receiving guidance from a trainer, treatment was conducted using the visual perception training therapy software (HVT, version number: V1.0.10000) on a network platform for 30 minutes per day, totaling 3 months.
Study 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.
Eligibility
Sex
ALL
Min age
4 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria
1. Aged 4-12 years, with no gender restriction;
2. Diagnosed with congenital ectopia lentis;
3. Underwent bilateral lensectomy combined with IOL scleral fixation, and within 1 month ± 1 week after the second-eye surgery;
4. 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;
5. Written informed consent signed by the patient and their parents or legal guardians.
Exclusion Criteria
1. History of ocular trauma or previous ocular surgery other than the study-related procedure;
2. Unable to cooperate with treatment, examinations, and follow-up assessments;
3. 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;
4. Presence of diplopia in either eye;
5. Known history of neurological disorders (e.g., photosensitive epilepsy);
6. Participation in other clinical trials within the postoperative period that may affect the outcomes of the present study;
7. 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.).
Primary outcome measure(s)
Change in BCVA relative to baseline in study eyes — From start of intervention to the end of intervention at 3 months The best corrected vision will be measured by a professional optometrist.
Trial sites (2)
Facility
City
Region
Status
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
Recruiting
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
Qingyuan
Guangdong
Not Yet Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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