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临床试验/NCT07096622
NCT07096622招募中不适用

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

Zhongshan Ophthalmic Center, Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
82
试验地点
2
主要终点
Change in BCVA relative to baseline in study eyes

研究概览

简要总结

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.

详细描述

Congenital ectopia lentis (CEL) is a hereditary ocular disorder caused by hypoplasia or dysfunction of the lens zonules, and is one of the major etiologies of congenital visual impairment in children and adolescents. Most patients with CEL are children within the critical period of visual development (0-12 years old). Sustained abnormal visual input due to congenital developmental anomalies severely interferes with the normal connection between retinal photoreceptors and the visual center, resulting in severe visual damage. At present, surgery is the main treatment for patients with severe CEL. However, clinical practice has shown that even after standardized surgical intervention and routine postoperative visual rehabilitation training, 36.8% of affected eyes still fail to achieve normal visual levels corresponding to their age. In addition, patients with CEL who undergo IOL scleral fixation often develop a certain degree of astigmatism due to postoperative tilt or decentration of the IOL, which further compromises the improvement of visual function.

In recent years, digital visual perceptual training (HVT), as a novel technique for amblyopia intervention, has attracted considerable attention. Studies have demonstrated that, compared with traditional refractive correction and occlusion therapy, visual perceptual training is characterized by faster visual acuity improvement, higher compliance, and the ability to enhance binocular visual function. Furthermore, as a form of visual perceptual training software, web-based visual perceptual training allows patients to complete training at home through gamified tasks. Meanwhile, training plans can be adjusted according to patients' conditions and progress, enabling personalized treatment regimens. This helps improve treatment compliance and patient experience, and facilitates remote management by hospitals. Notably, the meridional perceptual learning module in visual perceptual training can more effectively improve uncorrected visual function in patients with astigmatism. Nevertheless, no studies to date have focused on the efficacy of visual perceptual training in improving visual function in this specific population of patients with CEL.

This study intends to evaluate the efficacy and safety of visual perceptual training on postoperative visual function in patients with CEL, so as to provide evidence for formulating postoperative visual rehabilitation training strategies for these patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This study employs an open-label design without participant or investigator blinding, but with assessor blinding implemented. To reduce bias under non-blinded conditions, trial-related personnel involved in participant screening remain blinded, and clinical staff conducting regular ophthalmological examinations and data analysts are kept blinded to treatment allocation.

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.).

研究组 & 干预措施

intervention group

Experimental

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.

干预措施: perceptual learning visual treatment,HVT (Device)

compare group

No Intervention

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.

结局指标

主要结局

Change in BCVA relative to baseline in study eyes

时间窗: From start of intervention to the end of intervention at 3 months

The best corrected vision will be measured by a professional optometrist.

Change in BCVA relative to baseline in both eyes

时间窗: From start of intervention to the end of intervention at 3 months

The best corrected vision will be measured by a professional optometrist.

次要结局

  • Proportion of eyes with a relative improvement in BCVA of ≥2 lines from baseline(From start of intervention to the end of intervention at 3 months)
  • Changes in stereoscopic vision relative to the baseline(From start of intervention to the end of intervention at 3 months)
  • Change in quality of life score(From start of intervention to the end of intervention at 3 months)
  • adherence of intervention(From start of intervention to the end of intervention at 3 months)
  • adherence of intervention(From start of intervention to the end of intervention at 3 months)
  • Proportion of eyes with a relative improvement in BCVA of ≥2 lines from baseline(From start of intervention to the end of intervention at 3 months)
  • Changes in stereoscopic vision relative to the baseline(From start of intervention to the end of intervention at 3 months)
  • Change in quality of life score(From start of intervention to the end of intervention at 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangming Jin

Associate Chief Physician, Cataract Department

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (2)

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