NCT02887326

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

August 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

August 29, 2016

Last Update Submit

October 12, 2018

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (2)

  • Protein levels in tear fluid, saliva and blood(plasma)

    fall 2018

  • Ranch analysis of questionnaire

    fall 2018

Study Arms (4)

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

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with keratoconus residing in the Central Denmark Region

You may qualify if:

  • Keratoconus residint in the Central Denmark Region

You may not qualify if:

  • Other eye diseases
  • Ocular traumas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tear fluid, saliva and blood.

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 2, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

October 16, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share