Evaluation of the German Version of a Validated Keratoconus Questionaire (KORQ)

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus, Unspecified, Bilateral
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler University Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited in the keratoconus outpatient clinic as part of our routine checkups

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Difficulty in understanding patient information

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of Keratoconus Outcome Research Questionnaire (KORQ)	validation of a questionnaire in german language	at screening visit

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz
• Investigators: Principal Investigator: Matthias Bolz, Kepler University Hosiptal

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: KUK-Opthalmology-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No