NCT05572580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

October 5, 2022

Last Update Submit

March 5, 2024

Conditions

Keratoconus, Unspecified, Bilateral

Outcome Measures

Primary Outcomes (1)

  • Validation of Keratoconus Outcome Research Questionnaire (KORQ)

    validation of a questionnaire in german language

    at screening visit

Interventions

questionnaireOTHER

the patients are asked to fill in a questionnaire

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Difficulty in understanding patient information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Klinik

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Matthias Bolz

    Kepler University Hosiptal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

August 11, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

AU(1)