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Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery

Sponsor
Wenzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04521907
Collaborator
(none)
177
Enrollment
1
Location
113.1
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. We recorded patient demographics and incidence and risk factors for glaucoma-related adverse event. This study to identify the incidence of and risk factors associated with postoperative glaucoma at various durations after congenital cataract surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    177 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery
    Actual Study Start Date :
    May 1, 2011
    Anticipated Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Oct 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Group 1 includes patients who underwent cataract surgery with primary IOL implantation
    Group 2

    Group 2 includes patients who underwent cataract surgery with secondly IOL implantation
    Group 3

    Group 3 includes patients who underwent cataract surgery without IOL implantation.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of glaucoma after congenital cataract surgery [2020.6.30]

      The incidence of glaucoma at various durations after congenital cataract surgery

    2. Demographic data, including sex, age at surgery, gestational history, family history of cataract, and laterality of disease, were collected. [2020.6.30]

      Risk factors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 14 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients who underwent lensectomy combined with limited anterior vitrectomy, with or without IOL implantation for congenital cataract, all by one surgeon
    Exclusion Criteria:
    • Patient had a preoperative IOP above 21mmHg, glaucoma, coexistent uveitis, metabolic syndromes/diseases or exposure to radiation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmology and Optometry Hospital Wenzhou Zhejiang China 325027

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04521907
    Other Study ID Numbers:
    • GRAE2 -zzh
    First Posted:
    Aug 21, 2020
    Last Update Posted:
    Aug 21, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    Glaucoma
    Incidence
    Congenital cataract surgery
    Additional relevant MeSH terms:
    Glaucoma
    Cataract

    Study Results

    No Results Posted as of Aug 21, 2020