Keratoconus - Biomarkers and Questionnaire

October 12, 2018 updated by: University of Aarhus

The biomarker study adds to our previous study on biomarkers in tear fluid. In this study the investigators examine wether the biomarker levels are in correlation with the disease level and duration of disease.

The questionnaire study focuses on the patients perspective. With a validated questionnaire fore keratoconus patient it examine the patients self.-evaluated visual challenges and quality of life

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with keratoconus residing in the Central Denmark Region

Description

Inclusion Criteria:

  • Keratoconus residint in the Central Denmark Region

Exclusion Criteria:

  • Other eye diseases
  • Ocular traumas.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
age 15-25 years
Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples
age 25-35 years
Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples
age 35-45 year
Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples
> age 45 year
Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Protein levels in tear fluid, saliva and blood(plasma)
Time Frame: fall 2018
fall 2018
Ranch analysis of questionnaire
Time Frame: fall 2018
fall 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUH-3828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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