Glaucoma After Congenital Cataract Surgery

Sponsor
Sun Yat-sen University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04342052
Collaborator
(none)
351
1
168
2.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    351 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Glaucoma After Congenital Cataract Surgery
    Actual Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Apr 8, 2020
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. the incidence of glaucoma after congenital cataract surgery [baseline]

      A Kaplan-Meier analysis was used

    Secondary Outcome Measures

    1. Risk factors of glaucoma after congenital cataract surgery [baseline]

      Piecewise exponential survival models with mixed effects (PEWSMME) were used.(variables including demographic characters, surgery categories, clinical history, length of follow up).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haotian Lin, Principal Investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04342052
    Other Study ID Numbers:
    • CCPMOH2020
    First Posted:
    Apr 10, 2020
    Last Update Posted:
    Jun 1, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2021