GlaucomaNCT00804063
Serum Citrate in Diagnosis and Follow-up for Glaucoma
An observational study of Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- drawing blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2008to Jul 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary university center
Who may be able to join
- age> 18 years
- glaucoma
Who cannot join
- Active ocular inflammation
- Ocular Hypertension
- Nephropathy
- Alcohol-, Drug abuse
- Mitochondriopathy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.
- Conditions
- Glaucoma
- Being tested
- drawing blood sample
- Keywords
- glaucoma, citrate
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drawing blood sampleProcedure or surgery
fasting blood sample
| Study group | Role | What they receive |
|---|---|---|
| 1 | glaucoma patients Receives: Procedure: drawing blood sample | |
| 2 | non-glaucoma controls Receives: Procedure: drawing blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum citrate level
Measured: 1
Secondary outcomes (1)
urine citrate
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baselland Bruderholz
- Responsible party
- Sponsor
- Investigators
- David Goldblum, MD, Principal investigator, University Hospital, Basel, SwitzerlandJosef Flammer, MD, Study chair, University Hospital, Basel, SwitzerlandSelim Orguel, MD, Study director, University Hospital, Basel, SwitzerlandStephan Fraenkl, MD, Principal investigator, University Hospital, Basel, SwitzerlandFabrizio Branca, MD, Principal investigator, University Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804063
- Sponsor's protocol ID
- EK 325/08
- Status last verified
- Jan 2015
- First submitted
- 5 Dec 2008
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Citrate in Diagnosis and Follow-up for Glaucoma
- ClinicalTrials.gov ID
- NCT00804063
- Acronym / sponsor ID
- EK 325/08
- Conditions
- Glaucoma
- Keywords
- glaucoma, citrate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kantonsspital Baselland Bruderholz
- Study start
- Dec 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Dec 2008 (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.
Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: drawing blood sampleglaucoma patients |
| 2 | – | Procedure: drawing blood samplenon-glaucoma controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary university center
Key inclusion criteria (2 listed)
- age> 18 years
- glaucoma
Key exclusion criteria (5 listed)
- Active ocular inflammation
- Ocular Hypertension
- Nephropathy
- Alcohol-, Drug abuse
- Mitochondriopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drawing blood samplefasting blood sample | Procedure or surgery | 1, 2 |
Primary outcome
serum citrate level
Time frame: 1
1 secondary outcome
urine citrate
Time frame: 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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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.
David Goldblum, MD principal investigator
University Hospital, Basel, Switzerland
Josef Flammer, MD study chair
University Hospital, Basel, Switzerland
Selim Orguel, MD study director
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
serum citrate level (time frame: 1). 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 8 Jan 2015.