Visual and perceptual training to improve sight after congenital ectopia lentis surgery in children
Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children: A Randomized Controlled Clinical Trial
We will try a web-based visual and perceptual training program to see if it improves vision, stereoacuity, quality of life, and treatment adherence in children after surgery for congenital ectopia lentis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT07096622 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 4–12 years with congenital ectopia lentis who have had bilateral lensectomy with IOL scleral fixation and are around one month after their second-eye surgery, with best-corrected visual acuity between ≤20/200 and below the normal level for their age, are ideal candidates.
Not a fit: Children with a history of ocular trauma or previous non-study ocular surgery, severe coexisting eye conditions (e.g., recurrent lens dislocation, dense central cataract, secondary glaucoma, corneal endothelial decompensation, retinal detachment), or those unable to cooperate with treatment and follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could improve visual acuity, binocular vision, and quality of life for postoperative congenital ectopia lentis children while offering a scalable, home-delivered rehabilitation option.
How similar studies have performed: Digital visual perceptual training has shown promising, faster improvements in visual acuity and binocular function in amblyopia and related conditions, but its specific use after congenital ectopia lentis surgery is novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.