KORQ: Evaluation of the German Version of a Validated Keratoconus Questionaire

Sponsor

Johannes Kepler University of Linz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05572580

Collaborator

(none)

Enrollment

Location

11.7

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus, Unspecified, Bilateral	Other: questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of the German Version of a Validated Keratoconus Questionaire

Actual Study Start Date :

Aug 11, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

validation of a questionnaire [1 year]
validation of a questionnaire in german languae

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Difficulty in understanding patient information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kepler University Klinik	Linz	Upper Austria	Austria	4020

Sponsors and Collaborators

Johannes Kepler University of Linz

Investigators

Principal Investigator: Matthias Bolz, Kepler University Hosiptal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johannes Kepler University of Linz

ClinicalTrials.gov Identifier:

NCT05572580

Other Study ID Numbers:

KUK-Opthalmology-008

First Posted:

Oct 7, 2022

Last Update Posted:

Oct 7, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Keratoconus

Study Results

No Results Posted as of Oct 7, 2022