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Electrophysiology in Congenital Cataract After Lensectomy and Anterior

Sponsor
Wenzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04427748
Collaborator
(none)
116
Enrollment
1
Location
23
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E).

    electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    116 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Sep 12, 2019
    Actual Study Completion Date :
    Dec 3, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    congenital cataract group

    children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG
    age-matched normal children group

    age-matched normal children are perfomed ERG

    Outcome Measures

    Primary Outcome Measures

    1. ERG [at least 1year after the surgery of congenital cataract]

      investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Months to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation
    Exclusion Criteria:
    • patients with mild cataracts do not require surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hosptial of Wenzhou Medical College 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:
    yin ying zhao, Clinical professor, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04427748
    Other Study ID Numbers:
    • Electrophysiology-WJJ
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by yin ying zhao, Clinical professor, Wenzhou Medical University
    ERG
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Jun 11, 2020