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.
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;
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;
Parallel
perceptual learning visual treatment,HVT
DeviceAfter 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.
Change in BCVA relative to baseline in study eyes
The best corrected vision will be measured by a professional optometrist.
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.
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.
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%.
Click on the lead sponsor to view all of their trials.
