Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery

Sponsor
Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04976608
Collaborator
(none)
30
1
6.5
4.6

Study Details

Study Description

Brief Summary

To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    According to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.SD-OCT and MRI were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
    Actual Study Start Date :
    Jun 16, 2021
    Anticipated Primary Completion Date :
    Dec 30, 2021
    Anticipated Study Completion Date :
    Dec 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    The BCVA of eyes is greater than 0.6

    Group 2

    The BCVA of eyes is from 0.1 to 0.6

    Group 3

    The BCVA of eyes is less than 0.6

    Outcome Measures

    Primary Outcome Measures

    1. Macular thickness [2021.12.30]

      Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT.

    2. Subfoveal choroidal thickness [2021.12.30]

      Scan the Subfoveal choroid in enhanced scan mode with SD-OCT.

    3. Retinal nerve fiber layer thickness [2021.12.30]

      Scan concentric circles with a length of 3.4mm and a diameter ranging from 2.5mm to 4.0mm in 12 directions centered on the optic disc with SD-OCT.

    4. The volume of the lateral geniculate body [2021.12.30]

      Measure the volume of the lateral geniculate body by T1 phase scan of MRI

    5. The volume of the brodmann 17,18,19 area [2021.12.30]

      Masure the volume of the brodmann 17,18,19 area by T1 phase scan of MRI

    6. The FA of the white matter fiber bundle [2021.12.30]

      Measure the Fraction Anisotropy of the white matter fiber bundle related to visual signal transduction by DWI scan of MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age of 4-60 years

    • Congenital cataract surgery is planned

    • The operation was successful without any complications

    • Can cooperate well with OCT and MRI examinations

    Exclusion Criteria:
    • Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases

    • Behavioral, cognitive impairment

    • Developmental delay

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang China

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    • Study Director: Yune Zhao, Ophthalmology and Optometry Hospital

    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:
    NCT04976608
    Other Study ID Numbers:
    • amblyopia-LZL
    First Posted:
    Jul 26, 2021
    Last Update Posted:
    Jul 26, 2021
    Last Verified:
    Jul 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 Jul 26, 2021