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Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Sponsor
Wenzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04357249
Collaborator
(none)
50
Enrollment
1
Location
65.1
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. The investigators included children with cataract planning to have cataract surgery in our institute. Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. The investigators recorded age at surgery, gender and relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.All patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. Patients were followed for two years or until the development of severe VAO requiring Nd: YAG laser capsulotomy, whichever came first. The examinations consisted of visual acuity, IOP measurement by a Tonopen tonometer (Reichert, Inc., Seefeld, Germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).The primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.A paired T test was used to compare the areas of the PCO between the postoperative visits and baseline.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation
    Actual Study Start Date :
    Mar 1, 2015
    Anticipated Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Aug 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. area of PCO [2015.5.1- 2020.8-1]

      area of posterior capsular opening

    Eligibility Criteria

    Criteria

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

    Participants included eyes of children with unilateral or bilateral cataract.

    Exclusion Criteria:

    Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis, or surgical complications, as well as those whose pupils could not dilate normally postoperation or who could not complete the follow-up, were excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wenzhou Medical Colledge Wenzhou Zhejiang China 310000

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    • Study Director: ZHAO YUNE, MD, executive dean

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    yin ying zhao, yin ying zhao [yyzhao], Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04357249
    Other Study ID Numbers:
    • FYN-capsular
    First Posted:
    Apr 22, 2020
    Last Update Posted:
    Apr 22, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Apr 22, 2020