GlaucomaNCT00327509
mRNA Expression in Lymphocytes of Glaucoma Patients
An observational study of Glaucoma and Healthy Subjects, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A secondary objective is to analyze the impact of different forms of glaucoma or of a vasospastic propensity on the findings. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Healthy Subjects
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2004to Dec 2007
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: glaucoma patients, healthy subjects
Who may be able to join
- Glaucoma patients
- diagnosis of chronic glaucoma with typical glaucomatous disc and visual field damage
- a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment HTG)
- a present or past diurnal tension curve with an average intraocular pressure below 21 mmHg without treatment (NTG)
- a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment and signs of pseudoexfoliation in the anterior segment (PEX)
- a juvenile-onset open-angle glaucoma with a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment (Juvenile Glaucoma)
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- Healthy subjects
- no history of ocular disease
- no history of systemic disease
- no history of alcohol/drug abuse
- normal blood pressure (100-140 / 60-90 mmHg)
- best corrected visual acuity above 20/25 in both eyes
- no pathological findings upon a slit-lamp examination and indirect fundoscopy
- IOP < 20 mmHg in both eyes
Who cannot join
- Ametropia > 3 dpt
- Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
- Pigmentary dispersion
- any abnormality which in the physician's view would prevent reliable applanation tonometry
- History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis
- History of ocular trauma or intraocular surgery within the past 6 months
Show all 10Show fewer
- History of infection or inflammation within the past 3 months
- History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment
- Need for any concomitant medications that may interfere with the evaluation of ocular blood flow
- significant history and/or active alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Eye Clinic
Basel, Canton of Basel-City, 4031
About this study
Official title: Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients
The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A secondary objective is to analyze the impact of different forms of glaucoma or of a vasospastic propensity on the findings.
Read the detailed description
Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The glaucoma patients will be divided into four groups: (1) high tension glaucoma, (2) normal tension glaucoma, (3) pseudoexfoliation glaucoma, and (4) juvenile glaucoma. Healthy subjects are separated into two age groups. Vasospastic propensity will be assessed with a questionnaire: patients and subjects answering yes to the questions: "do you have always cold hands, even during summer time?" and "do other people tell you that you have cold hands?" will be classified as vasospastic, and as normals if they deny a history of cold hands. Blood will be drawn from an arm vein, lymphocytes will be isolated and mRNA of following genes will be assessed in these lymphocytes:
Nuclear proteins: NF-kappa B, XPGC, P53, XIAP; Multi-drug resistance proteins: ABC 1, ABC 8, MDR 3; Adhesion protein: ICAM 1; Blood brain barrier breakdown protein: P2Y; Energy metabolism proteins: Adrenodoxin, Adrenodoxin-reductase, Cytochrome p450, Cytochrome-reductase, Alcohol-dehydrogenase; Tissue remodeling proteins: MMP 9, MMP 8, MMP 14, TIMP 1, TIMP 2, TIMP 3, TIMP 4.
- Conditions
- Glaucoma, Healthy Subjects
- Keywords
- mRNA, glaucoma
- Medical subject headings
- Glaucoma
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 |
|---|---|---|
| 1-HTG | high tension glaucoma highest IOP > 21 mmHg | |
| 2-NTG | normal tension glaucoma highest measured IOP < 21 mmHg | |
| 3-PEX | pseudoexfoliation glaucoma PEX material visible | |
| 4-Juvenile | juvenile glaucoma | |
| 5-Control1 | healthy subjects (age group 1) | |
| 6-Control2 | healthy subjects (age group 2) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bonn
- Investigators
- Selim Orgül, MD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327509
- Sponsor's protocol ID
- 004-KAR-2004-001
- Status last verified
- Aug 2009
- First submitted
- 17 May 2006
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00327509
- Acronym / sponsor ID
- 004-KAR-2004-001
- Conditions
- Glaucoma, Healthy Subjects
- Keywords
- mRNA, glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Bonn
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 May 2006 (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 aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A secondary objective is to analyze the impact of different forms of glaucoma or of a vasospastic propensity on the findings.
Detailed description
Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The glaucoma patients will be divided into four groups: (1) high tension glaucoma, (2) normal tension glaucoma, (3) pseudoexfoliation glaucoma, and (4) juvenile glaucoma. Healthy subjects are separated into two age groups. Vasospastic propensity will be assessed with a questionnaire: patients and subjects answering yes to the questions: "do you have always cold hands, even during summer time?" and "do other people tell you that you have cold hands?" will be classified as vasospastic, and as normals if they deny a history of cold hands. Blood will be drawn from an arm vein, lymphocytes will be isolated and mRNA of following genes will be assessed in these lymphocytes:
Nuclear proteins: NF-kappa B, XPGC, P53, XIAP; Multi-drug resistance proteins: ABC 1, ABC 8, MDR 3; Adhesion protein: ICAM 1; Blood brain barrier breakdown protein: P2Y; Energy metabolism proteins: Adrenodoxin, Adrenodoxin-reductase, Cytochrome p450, Cytochrome-reductase, Alcohol-dehydrogenase; Tissue remodeling proteins: MMP 9, MMP 8, MMP 14, TIMP 1, TIMP 2, TIMP 3, TIMP 4.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1-HTG | – | –high tension glaucoma highest IOP > 21 mmHg |
| 2-NTG | – | –normal tension glaucoma highest measured IOP < 21 mmHg |
| 3-PEX | – | –pseudoexfoliation glaucoma PEX material visible |
| 4-Juvenile | – | –juvenile glaucoma |
| 5-Control1 | – | –healthy subjects (age group 1) |
| 6-Control2 | – | –healthy subjects (age group 2) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patients, healthy subjects
Key inclusion criteria (14 listed)
- Glaucoma patients
- diagnosis of chronic glaucoma with typical glaucomatous disc and visual field damage
- a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment HTG)
- a present or past diurnal tension curve with an average intraocular pressure below 21 mmHg without treatment (NTG)
- a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment and signs of pseudoexfoliation in the anterior segment (PEX)
Key exclusion criteria (10 listed)
- Ametropia > 3 dpt
- Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
- Pigmentary dispersion
- any abnormality which in the physician's view would prevent reliable applanation tonometry
- History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis
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
Not reported in the source record.
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 20 Aug 2009.
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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.
Selim Orgül, 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 and Healthy Subjects, 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 14 inclusion and 10 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 20 Aug 2009. 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.
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 20 Aug 2009.