Primary Open Angle GlaucomaNCT00465348
The Antioxidant Effect of Routine Vascular Therapy for Normal Tension Glaucoma Patients
An observational study of Primary Open Angle Glaucoma, run by University Hospital, Basel, Switzerland.
Trial summary
To quantify oxidative stress in circulating leukocytes of normal tension glaucoma patients, prior to and one month after routine vascular therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary open-angle glaucoma patients
Who may be able to join
- For NTG patients:
- A mean untreated intraocular pressure consistently equal to or below 21mmHg or median intraocular pressure equal to or below 20mmHg on diurnal testing (at least three measurements) with no single measurement greater than 24mmHg
- Open drainage angles on gonioscopy
- Typical optic disc damage with glaucomatous cupping and thinning of neuroretinal rim
- Visual field defect congruent to glaucomatous disc alteration
- No other pathological findings upon slit-lamp examination and indirect fundoscopy
Show all 14Show fewer
- Vasospastic propensity will be assumed if a clear history of frequent cold hands (answering yes to the questions:" Do you always have cold hands, even during the summer time?" and "Do other people tell you that you have cold hands?") is reported.
- For healthy subjects:
- An intraocular pressure < 20 mmHg
- No history of ocular or systemic disease
- No history of chronic or current systemic or topical medication, or of drug or alcohol abuse
- Normal blood pressure (100-140/60-90mm Hg)
- Best corrected visual acuity above 20/32 in both eyes
- No pathological findings upon slit-lamp examination and indirect fundoscopy
Who cannot join
- Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
- Pigmentary dispersion or pseudoexfoliation
- Evidence for any secondary cause for a glaucomatous optic neuropathy (trauma, steroids, uveitis)
- History of chronic or recurrent severe inflammatory eye disease (eg. scleritis, uveitis) or clinically significant or progressive retinal disease (eg. diabetic retinopathy)
- History of ocular trauma or intraocular surgery within the past 6 months
- History of systemic infection or inflammation within the past 3 months
- Need for any concomitant medications that may interfere with the evaluation of leukocytes (eg: steroids, immunosuppressives)
- Patients with a significant history and /or active alcohol or drug abuse (significant is defined as that which may influence results of the study)
About this study
To quantify oxidative stress in circulating leukocytes of normal tension glaucoma patients, prior to and one month after routine vascular therapy.
Read the detailed description
There are two accepted medical modalities for glaucoma treatment. The first, is a local application of an intraocular pressure (IOP) lowering drug. The second, is the application of systemic drugs to improve vascular regulation. In the present study we would like to investigate whether this systemic form of treatment, in addition to improving blood flow, also reduces systemic oxidative stress.
Vascular dysregulation is one of the major risk factors for glaucoma, in particular for normal tension glaucoma (NTG). In glaucoma patients blood flow is, on average, reduced not only in the eye but also in various other organs of the body, for example in the fingers. Such a systemic dysregulation leads to disturbed autoregulation and thereby to an unstable oxygen supply in the eye.This, in turn, leads to the formation of reactive oxygen species (ROS). These ROS are capable of damaging cells such as white blood cells; this damage, however, is reversible as nature has provided us with mechanisms to repair this damage. This reversible damage brought about by ROS, which is constantly being repaired in our body, is an indication for oxidative stress. Oxidative stress plays an important role in the pathogenesis of glaucoma.
The indications for oxidative stress can be quantified in our laboratory by the method of comet assay also known as single cell gel electrophoresis.
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- normal tension glaucoma, vascular dysregulation
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: investigator withdrew
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selim Orgül, MD, Study director, University Hospital Basel, Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465348
- Sponsor's protocol ID
- 085-Mom-2007
- Status last verified
- Oct 2012
- First submitted
- 24 Apr 2007
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Moenkemann H, Flammer J, Wunderlich K, Breipohl W, Schild HH, Golubnitschaja O. Increased DNA breaks and up-regulation of both G(1) and G(2) checkpoint genes p21(WAF1/CIP1) and 14-3-3 sigma in circulating leukocytes of glaucoma patients and vasospastic individuals. Amino Acids. 2005 Mar;28(2):199-205. doi: 10.1007/s00726-005-0169-x. Epub 2005 Jan 23.
PubMed 15723242
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antioxidant Effect of Routine Vascular Therapy for Normal Tension Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00465348
- Acronym / sponsor ID
- 085-Mom-2007
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- normal tension glaucoma, vascular dysregulation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigator withdrew
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Apr 2007 (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.
To quantify oxidative stress in circulating leukocytes of normal tension glaucoma patients, prior to and one month after routine vascular therapy.
Detailed description
There are two accepted medical modalities for glaucoma treatment. The first, is a local application of an intraocular pressure (IOP) lowering drug. The second, is the application of systemic drugs to improve vascular regulation. In the present study we would like to investigate whether this systemic form of treatment, in addition to improving blood flow, also reduces systemic oxidative stress.
Vascular dysregulation is one of the major risk factors for glaucoma, in particular for normal tension glaucoma (NTG). In glaucoma patients blood flow is, on average, reduced not only in the eye but also in various other organs of the body, for example in the fingers. Such a systemic dysregulation leads to disturbed autoregulation and thereby to an unstable oxygen supply in the eye.This, in turn, leads to the formation of reactive oxygen species (ROS). These ROS are capable of damaging cells such as white blood cells; this damage, however, is reversible as nature has provided us with mechanisms to repair this damage. This reversible damage brought about by ROS, which is constantly being repaired in our body, is an indication for oxidative stress. Oxidative stress plays an important role in the pathogenesis of glaucoma.
The indications for oxidative stress can be quantified in our laboratory by the method of comet assay also known as single cell gel electrophoresis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary open-angle glaucoma patients
Key inclusion criteria (14 listed)
- A mean untreated intraocular pressure consistently equal to or below 21mmHg or median intraocular pressure equal to or below 20mmHg on diurnal testing (at least three measurements) with no single measurement greater than 24mmHg
- Open drainage angles on gonioscopy
- Typical optic disc damage with glaucomatous cupping and thinning of neuroretinal rim
- Visual field defect congruent to glaucomatous disc alteration
- No other pathological findings upon slit-lamp examination and indirect fundoscopy
Key exclusion criteria (8 listed)
- Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
- Pigmentary dispersion or pseudoexfoliation
- Evidence for any secondary cause for a glaucomatous optic neuropathy (trauma, steroids, uveitis)
- History of chronic or recurrent severe inflammatory eye disease (eg. scleritis, uveitis) or clinically significant or progressive retinal disease (eg. diabetic retinopathy)
- History of ocular trauma or intraocular surgery within the past 6 months
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Background: PubMed 15723242Moenkemann H, Flammer J, Wunderlich K, Breipohl W, Schild HH, Golubnitschaja O. Increased DNA breaks and up-regulation of both G(1) and G(2) checkpoint genes p21(WAF1/CIP1) and 14-3-3 sigma in circulating leukocytes of glaucoma patients and vasospastic individuals. Amino Acids. 2005 Mar;28(2):199-205. doi: 10.1007/s00726-005-0169-x. Epub 2005 Jan 23.
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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, Eye Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by University Hospital, Basel, 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 8 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: withdrawn, as of the sponsor's last update on 25 Oct 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
On the ClinicalTrials.gov record for NCT00465348, which also lists 1 linked publication.
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 25 Oct 2012.