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The Cohort Study of Pediatric Cataract

The Cohort Study of Pediatric Cataract

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05472844
Enrollment
5000
Registered
2022-07-25
Start date
2022-08-22
Completion date
2032-02-01
Last updated
2022-09-27

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

Conditions

Pediatric Cataract

Keywords

congenital cataract, traumatic cataract, complicated cataract, ocular structure parameters, surgical/vision recovery timing and strategies, postoperative adverse effects, psychologic and cognitive function, artificial intelligence

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.

Interventions

None listed

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

* adults

Design outcomes

Primary

MeasureTime frameDescription
Incidence changes of postoperative complicationsBaseline and through study completion, an average of 1 yearIncidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on
Best-corrected visual acuity changesBaseline and through study completion, an average of 1 yearBest-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
Intraocular pressure changesBaseline and through study completion, an average of 1 yearIntraocular pressures are measured by NCT machine
Refractive power changesBaseline and through study completion, an average of 1 yearRefractive power are measured at baseline and every visit at least every 1 year
Ocular biological measurements changesBaseline and through study completion, an average of 1 yearOcular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance

Secondary

MeasureTime frameDescription
Other factors changesBaseline and through study completion, an average of 1 yearSleep, 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.
BMI changesBaseline and through study completion, an average of 1 yearBMI is measured by technicians in every visit
Blood pressure changesBaseline and through study completion, an average of 1 yearDiastolic and systolic blood pressure are measured by technicians in every visit
Stereopsis changesBaseline and through study completion, an average of 1 yearStereopsis is measured by Randot Stereotest
Optical coherence tomography (OCT) changesBaseline and through study completion, an average of 1 yearRetinal thickness is measured and analyzed by OCT

Countries

China

Contacts

Primary ContactZhenzhen Liu, PhD
liuzhenzhen@gzzoc.com+020 66618932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026