Evaluation of the German Version of a Validated Keratoconus Questionaire

NCT ID: NCT05572580

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-11

Study Completion Date

2023-08-30

Brief Summary

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Keratoconus, which results in thinning of the cornea, affects mainly young patients. The causes are currently only partially known. The aim of this study is the evaluation of a keratoconus questionnaire in German. Until now this questionnaire is only in use in English.

Within the study patients will be asked to fill out a questionnaire. The questionnaire deals with issues that are influenced by keratoconus: Visual impairment and its impact on quality of life. This questionnaire (KORQ) is an already validated questionnaire in English. Within this study we would like to translate the questionnaire and validate it in German.

Within this study 50 patients will be included for the validation of the questionnaire. Based on previous studies evaluating the Keratoconus Questionnaire (KORQ) in other languages, a number of 50 patients has been shown to be sufficient for validation.

No control examination is necessary for this study.

Detailed Description

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Conditions

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Keratoconus, Unspecified, Bilateral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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questionnaire

the patients are asked to fill in a questionnaire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Keratoconus
* Signing of a written consent form for participation in the study

Exclusion Criteria

* Difficulty in understanding patient information
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johannes Kepler University of Linz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Bolz

Role: PRINCIPAL_INVESTIGATOR

Kepler University Hosiptal

Locations

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Kepler University Klinik

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

Other Identifiers

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KUK-Opthalmology-008

Identifier Type: -

Identifier Source: org_study_id

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