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Subjective Perception of Ocular Prosthesis Wear

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04321382
Collaborator
(none)
100
Enrollment
1
Location
13
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The loss of an eye, whether congenital or acquired, is a severe psychological trauma with negative impact on the quality of life of the patient. While rehabilitation with a customized ocular prosthesis anatomically restores the facial appearance, the final outcome is largely determined by the subjective satisfaction of the patient. By investigating the level of subjective perception, the quality of care can be improved.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Subjective Perception of Ocular Prosthesis Wear
    Actual Study Start Date :
    Jan 1, 2019
    Actual Primary Completion Date :
    Feb 1, 2020
    Actual Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Quality of care [1 hour]

      disease specific score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • acquired anophthalmia

    • Informed consent

    • ocular prosthesis wear for minimum of 2 years

    Exclusion Criteria:

    • congenital anophthalmia

    • microphthalmia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04321382
    Other Study ID Numbers:
    • s61570
    First Posted:
    Mar 25, 2020
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anophthalmos

    Study Results

    No Results Posted as of Mar 25, 2020