Age-Related Macular DegenerationNCT00568191
Stratus Versus Cirrus OCT in AMD
An observational study of Age-Related Macular Degeneration and Choroidal Neovascularization, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Choroidal Neovascularization
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2007to 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged > 55 years of either sex presenting with age-related macular degeneration
Who may be able to join
- Age>55 years
- Age-related macular degeneration
Who cannot join
- Not consented patients
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, State of Vienna, A1030
Ilse Krebs, MD, +43171165 ext. 4607, Ilse.Krebs@wienkav.at
Ilse Krebs, MD
About this study
Official title: Reliability of Threshold Algorithm in Age-Related Macular Degeneration: Stratus Versus Cirrus OCT
The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected
- Keywords
- Age-related macular degeneration, choroidal neovascularization, Stratus OCT, Cirrus OCT
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
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 | retinal thickness program Stratus OCT software 4.0 | |
| 2 | retinal cube 200x200 program of Cirrus OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of algorithm failures assessed by Stratus OCT versus Cirrus OCT in the horizontal central line
Measured: only 1 examination
Secondary outcomes (1)
Number of algorrithm failures in Stratus versus Cirrus OCT assessed in the whole scan
Measured: 1 examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startOct 2007
- Study completionDec 2007 (estimated)
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 Age-Related Macular 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Ilse Krebs, Principal investigator, Ludwig Boltzmann Institute of Retinology and Biomicroscopic Lasersurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568191
- Sponsor's protocol ID
- EK 06-007-VK1
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2007
- Last updated
- 5 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Krebs I, Falkner-Radler C, Hagen S, Haas P, Brannath W, Lie S, Ansari-Shahrezaei S, Binder S. Quality of the threshold algorithm in age-related macular degeneration: Stratus versus Cirrus OCT. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):995-1000. doi: 10.1167/iovs.08-2617. Epub 2008 Nov 21.
PubMed 19029035
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Threshold Algorithm in Age-Related Macular Degeneration: Stratus Versus Cirrus OCT
- ClinicalTrials.gov ID
- NCT00568191
- Acronym / sponsor ID
- EK 06-007-VK1
- Keywords
- Age-related macular degeneration, choroidal neovascularization, Stratus OCT, Cirrus OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 5 Dec 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.
The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –retinal thickness program Stratus OCT software 4.0 |
| 2 | – | –retinal cube 200x200 program of Cirrus OCT |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 55 years of either sex presenting with age-related macular degeneration
Key inclusion criteria (2 listed)
- Age>55 years
- Age-related macular degeneration
Key exclusion criteria (1 listed)
- Not consented patients
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
Number of algorithm failures assessed by Stratus OCT versus Cirrus OCT in the horizontal central line
Time frame: only 1 examination
1 secondary outcome
Number of algorrithm failures in Stratus versus Cirrus OCT assessed in the whole scan
Time frame: 1 examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
- Derived from this study: PubMed 19029035Krebs I, Falkner-Radler C, Hagen S, Haas P, Brannath W, Lie S, Ansari-Shahrezaei S, Binder S. Quality of the threshold algorithm in age-related macular degeneration: Stratus versus Cirrus OCT. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):995-1000. doi: 10.1167/iovs.08-2617. Epub 2008 Nov 21.
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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.
Ilse Krebs principal investigator
Ludwig Boltzmann Institute of Retinology and Biomicroscopic Lasersurgery
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 Age-Related Macular Degeneration and Choroidal Neovascularization, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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 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: status not confirmed, as of the sponsor's last update on 5 Dec 2007. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilse Krebs, MD (+43171165 ext. 94607, Ilse.Krebs@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of algorithm failures assessed by Stratus OCT versus Cirrus OCT in the horizontal central line (time frame: only 1 examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568191, 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 5 Dec 2007.