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Efficacy of visual and perceptual training on visual function for operative congenital ectopia lentis children : a randomized controlled clinical trial

Efficacy of visual and perceptual training on visual function for operative congenital ectopia lentis children : a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108254
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital ectopia lentis (postoperative)

Interventions

intervention group:All-day refractive correction + visual perception training for 30 minutes per day
control group:All-day refractive correction

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Ages 4-12, no gender restrictions; 2. Previously diagnosed with congenital ectopia lentis; 3. Undergone bilateral lens extraction combined with intraocular lens suspension surgery, with the second eye within 1 month ± 1 week after surgery; 4. Best-corrected visual acuity in both eyes is no less than 20/200 but below the normal level for the corresponding age: for 4-year-old patients, best-corrected visual acuity in both eyes is no higher than 20/40; for patients aged 5 years and above, best-corrected visual acuity in both eyes is no higher than 20/30. 5. Patients and parents sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Previous history of ocular trauma or ocular surgery; 2. Unable to cooperate with treatment, examination, follow-up assessment. 3. Cases requiring urgent surgical intervention include recurrent lens dislocation, severe cataracts (dense, located along the visual axis, with a diameter of >3 mm and affecting central vision), secondary glaucoma, corneal endothelial cell decompensation, or retinal detachment. 4. Diplopia in either eye; 5. History of neurological disorders (such as photosensitive epilepsy); 6. Did not participate in other clinical trials that may affect the results of this trial after surgery. 7. No use of local/systemic medications that may cause visual impairment or other visual treatments (such as atropine eye drop suppression therapy, occlusion therapy, digital therapy, Bangerter filters, optical suppression, VR training, etc.) other than refractive correction in the past three months.

Design outcomes

Secondary

MeasureTime frame
Compliance with refractive correction and HVT at month 3 after the start of the intervention;Proportion of participants with =2 rows of BCVA improvement at month 3 after the start of the intervention;Change in stereopsis relative to baseline at month 3 after the start of the intervention;Amount of change in quality of survival score at month 3 after the start of the intervention;

Primary

MeasureTime frame
Incidence of adverse events related to this study at month 3 after the start of the intervention;Change in BCVA in Participants' Eyes Relative to Baseline at Month 3 After Start of Intervention;

Countries

China

Contacts

Public ContactJin,Guangming

The Zhongshan Ophthalmic Center,Sun Yat-sen University

jingm@mail2.sysu.edu.cn+86 20 6660 4125

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026