capsular: Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Sponsor
Yune Zhao (Other)
Overall Status
Completed
CT.gov ID
NCT04803097
Collaborator
(none)
62
1
43
1.4

Study Details

Study Description

Brief Summary

Lens capsular often changes after pediatric cataract surgery,causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens
    Actual Study Start Date :
    Jun 1, 2016
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jan 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    pediatric cataract group

    Children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China) between 2016 and 2019 were included in the study. Every surgery included posterior capsulorhexis or capsulotomy and anterior vitrectomy. Patients accept slit-lamp-adapted anterior segmental photography at 1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively.

    Outcome Measures

    Primary Outcome Measures

    1. PCOA [20.74 ± 7.89 months]

      A comparison of posterior capsular opening areas at the corresponding time points

    2. VATA [20.74 ± 7.89 months]

      A comparison of visual axis transparent areas at the corresponding time points

    Secondary Outcome Measures

    1. axial length growth [20.74 ± 7.89 months]

      The growth of axial length at the corresponding time points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 96 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Children (age 0.5~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.

    Exclusion Criteria:

    Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Yune Zhao

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04803097
    Other Study ID Numbers:
    • cataract- fuyana
    First Posted:
    Mar 17, 2021
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2021