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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • perceptual learning visual treatment,HVT

Treatment groups

82 Participants
are divided into 2 treatment groups