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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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.

Primary outcome measures

• Change in BCVA relative to baseline in study eyes [Time frame: From start of intervention to the end of intervention at 3 months]

Secondary outcome measures (3)

• Changes in stereoscopic vision relative to the baseline [Time frame: From start of intervention to the end of intervention at 3 months]
• Change in quality of life score [Time frame: From start of intervention to the end of intervention at 3 months]
• adherence of intervention [Time frame: From start of intervention to the end of intervention at 3 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of — Guangzhou
• Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital) — Qingyuan

Publications

• Yao Y, He Y, Wen Y, Feng L, Ye Q, Xu Z, Zhou Y, Pang Y, Yu W, Zhong Y, Li Q, Yuan J, Liu J, Li J. Factual Evidence on Digital Therapeutics in Pediatric Amblyopia: Insights into Rapid Axial Elongation Risk. Ophthalmology. 2025 Jun;132(6):661-670. doi: 10.1016/j.ophtha.2025.01.005. Epub 2025 Jan 13. PMID 39814322
• Xiao S, Angjeli E, Wu HC, Gaier ED, Gomez S, Travers DA, Binenbaum G, Langer R, Hunter DG, Repka MX; Luminopia Pivotal Trial Group. Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia. Ophthalmology. 2022 Jan;129(1):77-85. doi: 10.1016/j.ophtha.2021.09.001. Epub 2021 Sep 14. PMID 34534556
• Liu Z, Lin H, Jin G, Tan X, Qu B, Jin L, Chen X, Wang W, Han X, Xu J, Ying G, Han Y, He M, Congdon N, Chen W, Luo L, Liu Y. In-the-Bag Versus Ciliary Sulcus Secondary Intraocular Lens Implantation for Pediatric Aphakia: A Prospective Comparative Study. Am J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13. PMID 34653355
• Chen T, Deng M, Zhang M, Chen J, Chen Z, Jiang Y. Visual outcomes of lens subluxation surgery with Cionni modified capsular tension rings in Marfan syndrome. Sci Rep. 2021 Feb 4;11(1):2994. doi: 10.1038/s41598-021-82586-6. PMID 33542371
• Jia WN, Chen ZX, Wang YL, Shen X, Chen XY, Chen TH, Sun Y, Liu Y, Song LH, Huo QY, Jiang YX. Genotype Associated With Visual Prognosis in Patients With Congenital Ectopia Lentis Following Lens Surgery: A Prospective Cohort Study. Am J Ophthalmol. 2024 Dec;268:285-295. doi: 10.1016/j.ajo.2024.08.002. Epub 2024 Aug 8. PMID 39121940
• Ng K, Xu P, Jin G, Cheng W, Luo X, Ding X, Zheng D, Liu Y. Quantitative analysis of choriocapillaris flow deficits and choroidal thickness in children with Marfan syndrome. Br J Ophthalmol. 2024 Jan 29;108(2):274-279. doi: 10.1136/bjo-2022-322535. PMID 36575623
• Huo QY, Zhang RZ, Jia WN, Wang YL, Shen X, Chen XY, Chen TH, Liu Y, Song LH, Wang X, Lv Y, Chen ZX, Jiang YX. Corneal Biomechanics Are Associated With FBN1 Mutations in Patients With Marfan Syndrome and Ectopia Lentis. Invest Ophthalmol Vis Sci. 2025 Mar 3;66(3):23. doi: 10.1167/iovs.66.3.23. PMID 40062814

Identifiers

NCT: NCT07096622 · 2025KYPJ068-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗