Visual and perceptual training to improve sight after congenital ectopia lentis surgery in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, parallel-group randomized trial comparing web-based visual perceptual training (HVT) with routine postoperative rehabilitation in children who have undergone bilateral lensectomy with IOL scleral fixation for congenital ectopia lentis. Eligible participants are 4–12 years old and enrolled about one month after their second-eye surgery, with best-corrected visual acuity no worse than 20/200 but below age-normal levels. Primary outcomes include changes in visual function, with secondary outcomes of stereoacuity, quality of life scores, treatment compliance, and safety of the software-based intervention. The study is being conducted at Zhongshan Ophthalmic Center and affiliated hospitals in Guangdong, China to produce evidence-based recommendations for visual rehabilitation in this population.

Why it matters

Who can join: the full rules

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.).

Where it's 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 Recruiting
• Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
  Qingyuan, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Guangming Jin, M.D. — 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
• Study coordinator: Guangming Jin, Ph.D.
• Email: jinguangming@gzzoc.com
• Phone: +86 02066604125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.