Visual Quality and Contrast Sensitivity Function for Limbal Dermoid Children After Corneal Transplantation

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03447041
Collaborator
(none)
50
1
34
1.5

Study Details

Study Description

Brief Summary

This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well asa to analyze its relationship between visual quality.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Limbal dermoid(LD) is a congenital benign tumor that consist of overgrowths of epidermal appendages that influence vision and cause visual abnormalities due to the induced corneal astigmatism. A large proportion of patients, all of whom had epibular dermoids, has amblyopia. In a previous study, keratoplasty, such as LKP (Lamellar Keratoplasty) or PKP (Penetrating Keratoplasty), was shown to facilitate the reconstruction of appearance, and improve visual acuity significantly postoperatively. However, the reestablishment of visual acuity and visual function are always ignored by parents after visual appearance recovery. Several studies have evaluated the visual acuity and objective and subjective visual function of patients after keratoplasty. These outcomes include contrast sensitivity (CS), refractive error, graft clarity, anterior and posterior corneal higher order aberration, and vision-related quality of life. Although a subjective visual function assessment has been deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite clear grafts and relatively good visual acuity, and the visual function evaluation for LD were relatively less.

    50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination. Then the normal group would be covered by the positive spherical lens of 1.0D to 6.0D to repress the BCVA to 0.1 to 0.9 respectively to compare the visual functions with the keratoplasty patients on the same visual acuity.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Zhongshan Ophthalmic Center, Sun Yat-Sen University,China
    Actual Study Start Date :
    Mar 1, 2018
    Actual Primary Completion Date :
    Dec 30, 2020
    Actual Study Completion Date :
    Dec 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    the keratoplasty group

    Patients with limbal dermoid who accepted cornea transplantation surgery after 1 year were performed quick CSF from Adaptive Sensory Technology company

    the normal group

    normal children without ocular disease

    Outcome Measures

    Primary Outcome Measures

    1. The contrast sensitivity function tested by quick CSF in the keratoplasty group [on 1 year postkeratoplasty]

      The quick CSF (contrast sensitivity function) tests including AULCSF (the area under the log CSF) and Cutoff SF (Cutoff sensitivity function)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Accept the corneal transplantation based on the clinical diagnosis of ocular surface disease;

    • more than 7 and less than 60 years old;

    • absence of other ocular disorders and no history of eye surgery and other systemic diseases.

    Exclusion Criteria:
    • less than 7 or more than 60 years old;

    • with the history of eye surgery and other systemic diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Opthalmic Center Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    • Study Chair: Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin Yuan, Yuanjin PI group, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03447041
    Other Study ID Numbers:
    • ZOC20171217
    First Posted:
    Feb 27, 2018
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jin Yuan, Yuanjin PI group, Zhongshan Ophthalmic Center, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 7, 2021