- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927303
The Spectralis-Cirrus Study
June 8, 2010 updated by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1030
- Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
male or female persons aged more than 50 years with exudative age related macular degeneration
Description
Inclusion Criteria:
- Exudative age related macular degeneration
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2
|
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
|
group 2
intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1
|
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
|
group 3
intervention 2 sequence of observers: 1,2,1,2
|
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
|
group 4
intervention 2 sequence of observers: 2,1,2,1
|
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
|
group 5
intervention 1 sequence of observers 1,1,2,2
|
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
|
group 6
intervention 1 sequence of observers 2,2,1,1
|
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
|
group 7
intervention 2 sequence of observers: 1,1,2,2
|
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
|
group 8
intervention 2 sequence of observers: 2,2,1,1
|
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of examinations with correctly set threshold algorithm lines
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences of mean retinal thickness in the central region
Time Frame: 1 day
|
1 day
|
Differences of retinal volume
Time Frame: 1 day
|
1 day
|
Distance acuity
Time Frame: 1 day
|
1 day
|
Age
Time Frame: 1 day
|
1 day
|
Classification of the lesion
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Susanne Binder, MD, Prof, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
June 23, 2009
First Submitted That Met QC Criteria
June 23, 2009
First Posted (Estimate)
June 24, 2009
Study Record Updates
Last Update Posted (Estimate)
June 9, 2010
Last Update Submitted That Met QC Criteria
June 8, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-086-0609
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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