KeratoconusNCT02887326
Keratoconus - Biomarkers and Questionnaire
An observational study of Keratoconus, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Keratoconus
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with keratoconus residing in the Central Denmark Region
Who may be able to join
- Keratoconus residint in the Central Denmark Region
Who cannot join
- Other eye diseases
- Ocular traumas.
About this study
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
- Conditions
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Protein levels in tear fluid, saliva and blood(plasma)
Measured: fall 2018
Ranch analysis of questionnaire
Measured: fall 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 287 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887326
- Sponsor's protocol ID
- AUH-3828
- Status last verified
- Oct 2017
- First submitted
- 29 Aug 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratoconus - Biomarkers and Questionnaire
- ClinicalTrials.gov ID
- NCT02887326
- Acronym / sponsor ID
- AUH-3828
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with keratoconus residing in the Central Denmark Region
Key inclusion criteria (1 listed)
- Keratoconus residint in the Central Denmark Region
Key exclusion criteria (2 listed)
- Other eye diseases
- Ocular traumas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Protein levels in tear fluid, saliva and blood(plasma)
Time frame: fall 2018
Ranch analysis of questionnaire
Time frame: fall 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein levels in tear fluid, saliva and blood(plasma) (time frame: fall 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.