MedPath

The Cohort Study of Pediatric Cataract

Recruiting
Conditions
Pediatric Cataract
Registration Number
NCT05472844
Lead Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Brief Summary

This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.

Detailed Description

Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children (age \< 18 yo)before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
5000
Inclusion Criteria
  • aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent
Read More
Exclusion Criteria
  • adults
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Best-corrected visual acuity changesBaseline and through study completion, an average of 1 year

Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time

Ocular biological measurements changesBaseline and through study completion, an average of 1 year

Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance

Incidence changes of postoperative complicationsBaseline and through study completion, an average of 1 year

Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on

Intraocular pressure changesBaseline and through study completion, an average of 1 year

Intraocular pressures are measured by NCT machine

Refractive power changesBaseline and through study completion, an average of 1 year

Refractive power are measured at baseline and every visit at least every 1 year

Secondary Outcome Measures
NameTimeMethod
BMI changesBaseline and through study completion, an average of 1 year

BMI is measured by technicians in every visit

Other factors changesBaseline and through study completion, an average of 1 year

Sleep, depression, cognitive function are measured by questionnaires. Self-Rating Scale of Sleep: minimum value-1 point, maximum value-50, and higher scores mean worse outcome. Hamilton Depression Scale: \<7 points-normal, and higher scores mean worse outcome. Loewenstein Cognitive Assessment: for every question, minimum 1 point, and maximum 4 points. Higher scores mean worse outcomes.

Blood pressure changesBaseline and through study completion, an average of 1 year

Diastolic and systolic blood pressure are measured by technicians in every visit

Stereopsis changesBaseline and through study completion, an average of 1 year

Stereopsis is measured by Randot Stereotest

Optical coherence tomography (OCT) changesBaseline and through study completion, an average of 1 year

Retinal thickness is measured and analyzed by OCT

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center

🇨🇳

Guangzhou, Guangdong, China

© Copyright 2025. All Rights Reserved by MedPath