Primary Open Angle GlaucomaNCT00284440
Choroidal Blood Flow Response to Hand-grip Test in Progressive Glaucoma
An observational study of Primary Open Angle Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2006to Jun 2011
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with glaucoma
Who may be able to join
None listed.
Who cannot join
- Ametropia > 3dpt
- Inadequate transparency of ocular media as defined by physical examination
- Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
- Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of at least one eye
- 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 9Show 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
- Patients with a significant history and/or active alcohol or drug abuse (significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Visual Field Progression in Glaucoma and Choroidal Blood Flow Response to the Hand-grip Test
The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.
Read the detailed description
Glaucoma is a worldwide leading cause of blindness. The key features of glaucoma are damage to the optic nerve head and progressive visual field defect, which is not necessarily only related to an increase in intraocular pressure. It has been suggested that ocular blood flow alterations in glaucoma are related to systemic vascular dysregulations.The hand-grip test has been suggested as a potential tool to unravel vascular dysregulation in the ocular circulation. Although applied routinely in clinical practice, a proper study testing the effectiveness of this test is lacking. The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Visual field progression, Choroidal blood flow
- Medical subject headings
- Glaucoma, Open-Angle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: enrollment problems
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 Orguel, MD, Principal investigator, Chief of department of diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284440
- Sponsor's protocol ID
- 072-Leh-2005-001
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2006
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gugleta K, Orgul S, Hasler PW, Picornell T, Gherghel D, Flammer J. Choroidal vascular reaction to hand-grip stress in subjects with vasospasm and its relevance in glaucoma. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1573-80. doi: 10.1167/iovs.02-0521.
PubMed 12657594
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Visual Field Progression in Glaucoma and Choroidal Blood Flow Response to the Hand-grip Test
- ClinicalTrials.gov ID
- NCT00284440
- Acronym / sponsor ID
- 072-Leh-2005-001
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Visual field progression, Choroidal blood flow
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: enrollment problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Jan 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 present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.
Detailed description
Glaucoma is a worldwide leading cause of blindness. The key features of glaucoma are damage to the optic nerve head and progressive visual field defect, which is not necessarily only related to an increase in intraocular pressure. It has been suggested that ocular blood flow alterations in glaucoma are related to systemic vascular dysregulations.The hand-grip test has been suggested as a potential tool to unravel vascular dysregulation in the ocular circulation. Although applied routinely in clinical practice, a proper study testing the effectiveness of this test is lacking. The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with glaucoma
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Ametropia > 3dpt
- Inadequate transparency of ocular media as defined by physical examination
- Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
- Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of at least one eye
- 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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Background: PubMed 12657594Gugleta K, Orgul S, Hasler PW, Picornell T, Gherghel D, Flammer J. Choroidal vascular reaction to hand-grip stress in subjects with vasospasm and its relevance in glaucoma. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1573-80. doi: 10.1167/iovs.02-0521.
- University Eye Clinic Basel, SwitzerlandLink provided by the sponsor.
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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 Orguel, MD principal investigator
Chief of department of diagnostics
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 Primary Open Angle 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 0 inclusion and 9 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 10 Mar 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 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 NCT00284440, 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 10 Mar 2015.