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NCT04342052 Clinical Trial

Glaucoma After Congenital Cataract Surgery

Glaucoma Clinical Trial

Official title:
Glaucoma After Congenital Cataract Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04342052
Other study ID # CCPMOH2020
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date December 31, 2024

Study information
Verified date May 2021
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.

Description:

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 351
Est. completion date December 31, 2024
Est. primary completion date April 8, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies; - cataract surgery performed in ZOC; - age at cataract removal younger than 16 years; Exclusion Criteria: - the preoperative IOP was above 21 mm Hg; - family history of glaucoma; - signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift; - ocular trauma history; - previous surgery intervention and - they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of glaucoma after congenital cataract surgery A Kaplan-Meier analysis was used baseline
Secondary Risk factors of glaucoma after congenital cataract surgery Piecewise exponential survival models with mixed effects (PEWSMME) were used.(variables including demographic characters, surgery categories, clinical history, length of follow up). baseline
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