Retinal DegenerationNCT00403195
Clinical and Pathophysiological Description of Ocular Ischemic Syndrome
An observational study of Retinal Degeneration and Diabetic Retinopathy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to characterize the disease Ocular Ischemic Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Degeneration, Diabetic Retinopathy
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2006to Jan 2009
- 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: Patients with the disease ocular ishemic syndrome. Patients will be screened through vascular surgery departments.
Who may be able to join
- Ocular ischemic syndrome
Who cannot join
- Any other active ocular disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen
Glostrup Municipality, 2600
About this study
Official title: Pathophysiological Analysis of Ocular Ischemic Syndrome and the Response to Vascular Surgery
The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.
Read the detailed description
The disease Ocular Ischemic Syndrome (OIS) is not a well described entity. It occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. In this study we will analyze why OIS is developed in some patients and not developed in others. The patients with OIS will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. Furthermore the impact of vascular surgery on OIS will be analyzed.
- Conditions
- Retinal Degeneration, Diabetic Retinopathy
- Keywords
- Ocular Ischemic Syndrome
- Medical subject headings
- Retinal Degeneration, Diabetic Retinopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2009
- Study completionJan 2009
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 Retinal DegenerationStudies of the same condition, open and under way.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Peter Kofoed, Glostrup University Hospital, Copenhagen
- Investigators
- Michael Larsen, Professor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403195
- Sponsor's protocol ID
- OIS
- Status last verified
- Sep 2012
- First submitted
- 21 Nov 2006
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kofoed PK, Munch IC, Sander B, Holfort SK, Sillesen H, Jensen LP, Larsen M. Prolonged multifocal electroretinographic implicit times in the ocular ischemic syndrome. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1806-10. doi: 10.1167/iovs.09-4555. Epub 2009 Nov 20.
PubMed 19933192
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Analysis of Ocular Ischemic Syndrome and the Response to Vascular Surgery
- ClinicalTrials.gov ID
- NCT00403195
- Acronym / sponsor ID
- OIS
- Conditions
- Retinal Degeneration, Diabetic Retinopathy
- Keywords
- Ocular Ischemic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Hospital, Gentofte, Copenhagen
- Study start
- Nov 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Nov 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 purpose of this study is to characterize the disease Ocular Ischemic Syndrome.
Detailed description
The disease Ocular Ischemic Syndrome (OIS) is not a well described entity. It occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. In this study we will analyze why OIS is developed in some patients and not developed in others. The patients with OIS will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. Furthermore the impact of vascular surgery on OIS will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the disease ocular ishemic syndrome. Patients will be screened through vascular surgery departments.
Key inclusion criteria (1 listed)
- Ocular ischemic syndrome
Key exclusion criteria (1 listed)
- Any other active ocular disease
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 10 Sep 2012.
- Derived from this study: PubMed 19933192Kofoed PK, Munch IC, Sander B, Holfort SK, Sillesen H, Jensen LP, Larsen M. Prolonged multifocal electroretinographic implicit times in the ocular ischemic syndrome. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1806-10. doi: 10.1167/iovs.09-4555. Epub 2009 Nov 20.
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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.
Michael Larsen, Professor study director
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 Retinal Degeneration and Diabetic Retinopathy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 1 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 10 Sep 2012. 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 Denmark. 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?
On the ClinicalTrials.gov record for NCT00403195, 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 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.