RecruitingNot ApplicableNCT07096622

Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children

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


Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Enrollment

82 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 12 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria7

  • 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.).

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Interventions

DEVICEperceptual 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.


Locations(2)

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

Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)

Qingyuan, Guangdong, China

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NCT07096622


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