Evaluation of the German Version of a Validated Keratoconus Questionaire

Keratoconus, Unspecified, Bilateral Clinical Trial

— KORQ  

Official title:

Evaluation of the German Version of a Validated Keratoconus Questionaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572580
• Other study ID #: KUK-Opthalmology-008
• Status: Completed
• Start date: August 11, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: March 2024
• Source: Johannes Kepler University of Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria:

• Keratoconus

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

Exclusion Criteria:

• Difficulty in understanding patient information

Related Conditions & MeSH terms

• Keratoconus
• Keratoconus, Unspecified, Bilateral

Intervention

Other:
• questionnaire
the patients are asked to fill in a questionnaire

Locations

Country	Name	City	State
Austria	Kepler University Klinik	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Kepler University of Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of Keratoconus Outcome Research Questionnaire (KORQ)	validation of a questionnaire in german language	at screening visit