Isolated Ectopia Lentis Clinical Trials

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Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children: A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
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
RECRUITING
Guangzhou
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
NOT_YET_RECRUITING
Qingyuan
Contact Information
Primary
Guangming Jin, Ph.D.
jinguangming@gzzoc.com
+86 02066604125
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 82
Treatments
Experimental: intervention group
Participants in the intervention group will undergo refraction at baseline and be prescribed appropriately powered spectacles based on the refraction results, which they will wear full-time. Following instruction from a trainer, they will receive training via the online platform of the visual perceptual training therapy software (HVT, Version: V1.0.10000) for 30 minutes daily for a total duration of 3 months. Follow-up visits and ophthalmic examinations will be conducted at 1, 2, and 3 months after trial initiation.
No_intervention: compare group
Participants in the control group will undergo refraction at baseline and be prescribed appropriately powered spectacles based on the refraction results, which they will wear full-time. They will receive occlusion therapy in accordance with the Amblyopia Preferred Practice Pattern (2024) issued by the American Academy of Ophthalmology for a total duration of 3 months. Follow-up visits and ophthalmic examinations will be conducted at 1, 2, and 3 months after trial initiation.
Related Therapeutic Areas
Sponsors
Leads: Zhongshan Ophthalmic Center, Sun Yat-sen University

This content was sourced from clinicaltrials.gov