NCT07096622|RecruitingDMC
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Sponsor study identifier
interventional
82
1 country
2
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2025
Actual (reported)July 31, 2025
Actual (reported)June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
Qingyuan, Guangdong, 511500, China
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.
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.
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
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
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
First Submitted
July 24, 2025
First Posted
July 31, 2025
Study Start
June 1, 2026
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 27, 2026
Record last verified: 2025-08
Study protocol and results will be published in a peer-reviewed journal.
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Source: ClinicalTrials.gov.
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