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Ectopia LentisNCT07096622

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

A study testing perceptual learning visual treatment,HVT in people with Ectopia Lentis and Lens Subluxation or Dislocation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 12 years
What is being tested?
perceptual learning visual treatment,HVT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
2 sitesChina
Study dates
1 Jun 2026to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting
  • 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

    Haotian Lin, M.D., +86 020-66607666, gddlht@aliyun.com

    Guangming Jin, M.D.

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

    Qingyuan, Guangdong, 511500

    Tingting Yang, 13620507831, qyrykyb@163.com

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
perceptual learning visual treatment,HVT
Medical subject headings
Ectopia Lentis, Lens Subluxation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perceptual learning visual treatment,HVTDevice

    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.

Study groups in NCT07096622
Study groupRoleWhat they receive
intervention groupExperimentalParticipants 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.
Receives: Device: perceptual learning visual treatment,HVT
compare groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BCVA relative to baseline in study eyes

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

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

Secondary outcomes (3)
  1. Changes in stereoscopic vision relative to the baseline

    Measure near stereopsis using the BUTTERFLY STEROTEST's STEREOTEST-ANIMALS part at 40 cm(16 inches) distance, wearing a pair of Standard 3-D Viewers.The angle of stereopsis of participants will be classified to 400 seconds,200 seconds and 100 seconds if they could recognize the 3-D cat, rabbit or monkey.

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

  2. Change in quality of life score

    This study used the PedsQL 4.0 Chinese version questionnaire to assess participants' quality of life at baseline, fisrt month, second month and third month. Participants will be asked to finish this questionnaire in paper.

    Participants aged 4 years should have their parents complete the questionnaire on their behalf. Participants aged 5-7 years should have the questionnaire completed by the researcher based on the child's responses after questioning the child. Participants aged 8-12 years should complete the questionnaire themselves. When participants did not understand the meaning of the questionnaire or had questions about the options, the researcher or parent should explain it to them and assist them in completing the questionnaire.

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

  3. adherence of intervention

    Compliance with refractive correction is recorded in the case report form through self-reporting at each follow-up visit.

    Compliance with visual perception training therapy software (HVT) will be automatically monitored through the system backend.

    Compliance with refractive correction will be calculated by dividing the average actual time spent wearing glasses per day over the past week, as recalled by participants during follow-up, by the average time spent awake per day, multiplied by 100%. Compliance with visual perception training will be calculated by dividing the actual number of days participants completed the training during follow-up by the number of days since the intervention began, multiplied by 100%.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, multi-center, parallel-group randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096622
Sponsor's protocol ID
2025KYPJ068-2
Status last verified
Aug 2025
First submitted
24 Jul 2025
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and results will be published in a peer-reviewed journal.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40062814

Questions about this trial

What is this clinical trial studying?

A study testing perceptual learning visual treatment,HVT in people with Ectopia Lentis and Lens Subluxation or Dislocation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guangming Jin, Ph.D. (+86 02066604125 ext. 13560035613, jinguangming@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BCVA relative to baseline in study eyes (time frame: From start of intervention to the end of intervention at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07096622, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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