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Glaucoma After Congenital And Infantile Cataract Surgery

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04131114
Collaborator
(none)
241
Enrollment
1
Location
131
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.

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 2021 was performed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    241 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China
    Actual Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 30, 2019
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. the incidence of suspected glaucoma/glaucoma after congenital cataracts [3 years]

      A Kaplan-Meier analysis was used.

    2. Risk Factors of suspected glaucoma/glaucoma after congenital cataracts [3 years]

      Cox regression analysis was assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • a diagnosis of congenital/infantile cataracts without any surgical intervention;

    • age younger than 10 years;

    • cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment

    Exclusion Criteria:

    • a preoperative IOP above 21 mm Hg;

    • the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;

    • the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center 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:
    NCT04131114
    Other Study ID Numbers:
    • CCPMOH2016-China-0303
    First Posted:
    Oct 18, 2019
    Last Update Posted:
    Apr 9, 2020
    Last Verified:
    Apr 1, 2020
    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:
    Glaucoma
    Cataract

    Study Results

    No Results Posted as of Apr 9, 2020