Exudative Age Related Macular DegenerationNCT00927303
The Spectralis-Cirrus Study
An observational study of Exudative Age Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age Related Macular Degeneration
- What is being tested?
- Cirrus-Spectralis and Spectralis-Cirrus
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2009to Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male or female persons aged more than 50 years with exudative age related macular degeneration
Who may be able to join
- Exudative age related macular degeneration
Who cannot join
- Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
- Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
- Not consented patients
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, State of Vienna, 1030
About this study
Official title: Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines
Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. This study is conducted to compare the quality of the examinations of to different spectral domain OCT machines concerning the positioning of algorithm lines. Furthermore the reproducibility of the examinations id tested, both machines provide different techniques to guarantee that in repeated examinations the same location is examined.
- Being tested
- Cirrus-Spectralis, Spectralis-Cirrus
- Keywords
- retinal thickness, threshold algorithm, optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cirrus-SpectralisDevice
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
Spectralis-CirrusDevice
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2 Receives: Device: Cirrus-Spectralis | |
| group 2 | intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1 Receives: Device: Cirrus-Spectralis | |
| group 3 | intervention 2 sequence of observers: 1,2,1,2 Receives: Device: Spectralis-Cirrus | |
| group 4 | intervention 2 sequence of observers: 2,1,2,1 Receives: Device: Spectralis-Cirrus | |
| group 5 | intervention 1 sequence of observers 1,1,2,2 Receives: Device: Cirrus-Spectralis | |
| group 6 | intervention 1 sequence of observers 2,2,1,1 Receives: Device: Cirrus-Spectralis | |
| group 7 | intervention 2 sequence of observers: 1,1,2,2 Receives: Device: Spectralis-Cirrus | |
| group 8 | intervention 2 sequence of observers: 2,2,1,1 Receives: Device: Spectralis-Cirrus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of examinations with correctly set threshold algorithm lines
Measured: 1 day
Secondary outcomes (5)
Differences of mean retinal thickness in the central region
Measured: 1 day
Differences of retinal volume
Measured: 1 day
Distance acuity
Measured: 1 day
Age
Measured: 1 day
Classification of the lesion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 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 Exudative 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Binder, MD, Prof, Study chair, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927303
- Sponsor's protocol ID
- 09-086-0609
- Status last verified
- Jun 2010
- First submitted
- 23 Jun 2009
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Krebs I, Smretschnig E, Moussa S, Brannath W, Womastek I, Binder S. Quality and reproducibility of retinal thickness measurements in two spectral-domain optical coherence tomography machines. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):6925-33. doi: 10.1167/iovs.10-6612.
PubMed 21791591
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines
- ClinicalTrials.gov ID
- NCT00927303
- Acronym / sponsor ID
- 09-086-0609
- Keywords
- retinal thickness, threshold algorithm, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Jun 2009 (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.
Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. This study is conducted to compare the quality of the examinations of to different spectral domain OCT machines concerning the positioning of algorithm lines. Furthermore the reproducibility of the examinations id tested, both machines provide different techniques to guarantee that in repeated examinations the same location is examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Cirrus-SpectralisIntervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2 |
| group 2 | – | Device: Cirrus-Spectralisintervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1 |
| group 3 | – | Device: Spectralis-Cirrusintervention 2 sequence of observers: 1,2,1,2 |
| group 4 | – | Device: Spectralis-Cirrusintervention 2 sequence of observers: 2,1,2,1 |
| group 5 | – | Device: Cirrus-Spectralisintervention 1 sequence of observers 1,1,2,2 |
| group 6 | – | Device: Cirrus-Spectralisintervention 1 sequence of observers 2,2,1,1 |
| group 7 | – | Device: Spectralis-Cirrusintervention 2 sequence of observers: 1,1,2,2 |
| group 8 | – | Device: Spectralis-Cirrusintervention 2 sequence of observers: 2,2,1,1 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male or female persons aged more than 50 years with exudative age related macular degeneration
Key inclusion criteria (1 listed)
- Exudative age related macular degeneration
Key exclusion criteria (3 listed)
- Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
- Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cirrus-Spectralis512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter | Device | Group 1, group 2, group 5, group 6 |
| Spectralis-Cirrusretinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter | Device | group 3, group 4, group 7, group 8 |
Primary outcome
Number of examinations with correctly set threshold algorithm lines
Time frame: 1 day
5 secondary outcomes
Differences of mean retinal thickness in the central region
Time frame: 1 day
Differences of retinal volume
Time frame: 1 day
Distance acuity
Time frame: 1 day
Age
Time frame: 1 day
Classification of the lesion
Time frame: 1 day
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 9 Jun 2010.
- Derived from this study: PubMed 21791591Krebs I, Smretschnig E, Moussa S, Brannath W, Womastek I, Binder S. Quality and reproducibility of retinal thickness measurements in two spectral-domain optical coherence tomography machines. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):6925-33. doi: 10.1167/iovs.10-6612.
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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.
Susanne Binder, MD, Prof study chair
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
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 Exudative Age Related Macular Degeneration, 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 1 inclusion and 3 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 9 Jun 2010. 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?
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.
What does the primary outcome measure?
Number of examinations with correctly set threshold algorithm lines (time frame: 1 day). 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 NCT00927303, 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 9 Jun 2010.