NCT00927303|Completed
The Spectralis-Cirrus Study
Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines
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Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines
Sponsor study identifier
observational
110
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2009
Actual (reported)June 24, 2009
Actual (reported)July 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Actual (reported)December 2009
Actual (reported)Number of examinations with correctly set threshold algorithm lines
1 day
Differences of mean retinal thickness in the central region
1 day
Differences of retinal volume
1 day
Distance acuity
1 day
Age
1 day
Classification of the lesion
1 day
Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2
intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1
intervention 2 sequence of observers: 1,2,1,2
intervention 2 sequence of observers: 2,1,2,1
intervention 1 sequence of observers 1,1,2,2
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
male or female persons aged more than 50 years with exudative age related macular degeneration
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, State of Vienna, 1030, Austria
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.
male or femal persons age over 50 years with exudative age-related macular degeneration
Susanne Binder, MD, Prof
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
First Submitted
June 23, 2009
First Posted
June 24, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)intervention 1 sequence of observers 2,2,1,1
intervention 2 sequence of observers: 1,1,2,2
intervention 2 sequence of observers: 2,2,1,1
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 2009
Actual (reported)Last Updated
June 9, 2010
Record last verified: 2010-06
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Source: ClinicalTrials.gov.
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