NCT07096622

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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 proportion of patients achieving ≥2 lines improvement in best-corrected visual acuity (BCVA), changes 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.

Detailed description

Congenital ectopia lentis (CEL) is commonly observed in patients with Marfan syndrome. It is a rare genetic eye disorder caused by abnormal development of the lens zonules, leading to displacement of the lens from its normal anatomical position. In addition to abnormalities in the development of refractive media such as the cornea and lens, these patients may also exhibit abnormalities in the photoreceptive system, including the retina. Furthermore, because patients receive abnormal visual input stimuli during the critical period of visual development, this often leads to the development of amblyopia. Currently, for patients with severe visual impairment due to lens dislocation, the standard treatment involves lens extraction combined with primary intraocular lens implantation. However, for patients with amblyopia following CEL surgery, conventional full-time refractive correction cannot prevent residual amblyopia. Additionally, patients who undergo extracapsular intraocular lens implantation may experience astigmatism due to potential postoperative lens tilt, which can impair visual function and mental health. Visual perceptual training therapy (HVT) is an emerging treatment modality for amblyopia. Studies have shown that compared to traditional refractive correction and occlusion therapy, visual perceptual training therapy offers faster visual acuity improvement, higher compliance, and the ability to enhance binocular visual function. Furthermore, existing research indicates that for patients with anisometropic or small-angle strabismic amblyopia, the efficacy of visual perceptual training combined with refractive correction is superior to refractive correction alone. As a form of visual perceptual training software, web-based visual perceptual training therapy enables patients to complete training at home through game-based activities. It can also adjust training plans based on patients' conditions and training progress, offering personalized treatment plans to improve treatment compliance and patient experience while enabling remote management by hospitals. The meridional perceptual learning module is particularly effective in improving uncorrected visual function related to astigmatism in patients following CEL surgery. However, to date, no studies have focused on the efficacy of visual perceptual training therapy in improving visual function for this specific population of patients with postoperative CEL.

Conditions

• Ectopia Lentis
• Lens Subluxation or Dislocation

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2025-07-31
• Last updated: 2026-04-16

Locations

1 site across 1 country: China