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Clinical Trials/NCT05472844
NCT05472844
Recruiting
N/A

The Cohort Study of Pediatric Cataract

Zhongshan Ophthalmic Center, Sun Yat-sen University1 site in 1 country5,000 target enrollmentAugust 22, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Cataract
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment
5000
Locations
1
Primary Endpoint
Best-corrected visual acuity changes
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 22, 2022
End Date
February 1, 2032
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yizhi Liu

Professor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • aged \< 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Best-corrected visual acuity changes

Time Frame: Baseline 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 changes

Time Frame: Baseline 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 complications

Time Frame: Baseline 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 changes

Time Frame: Baseline and through study completion, an average of 1 year

Intraocular pressures are measured by NCT machine

Refractive power changes

Time Frame: Baseline and through study completion, an average of 1 year

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

Secondary Outcomes

  • Other factors changes(Baseline and through study completion, an average of 1 year)
  • BMI changes(Baseline and through study completion, an average of 1 year)
  • Blood pressure changes(Baseline and through study completion, an average of 1 year)
  • Stereopsis changes(Baseline and through study completion, an average of 1 year)
  • Optical coherence tomography (OCT) changes(Baseline and through study completion, an average of 1 year)

Study Sites (1)

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