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

NCT07096622 | Recruiting DMC

• 1 other identifier: 2025KYPJ068-2
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ectopia Lentis; Lens Subluxation or Dislocation

Outcome Measures

Primary Outcomes (1)

• Change in BCVA relative to baseline in study eyes

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

  From start of intervention to the end of intervention at 3 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Device: perceptual learning visual treatment,HVT

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.

Interventions

perceptual learning visual treatment,HVT DEVICE

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.

intervention group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (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, 510060, China

RECRUITING

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

Qingyuan, Guangdong, 511500, China

NOT YET RECRUITING

Related Publications (7)

• 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 RESULT

• 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. Erratum In: Ophthalmology. 2022 May;129(5):593. doi: 10.1016/j.ophtha.2022.02.012.

  PMID: 34534556 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Ectopia Lentis; Lens Subluxation

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Lens Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Guangming Jin, M.D.

  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

  PRINCIPAL INVESTIGATOR

• Zhenzhen Liu, M.D.

  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

  STUDY CHAIR

• Danying Zheng, M.D.

  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

  STUDY CHAIR

Central Study Contacts

Guangming Jin, Ph.D.

CONTACT

+86 02066604125; jinguangming@gzzoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Cataract Department

Model Details: Open-label, multi-center, parallel-group randomized controlled trial

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available on December 2030 for 10 years.
• Access Criteria: Data are available upon reasonable request by contacting with the corresponding author.

Locations

CN (2)