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The Spectralis-Cirrus Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927303
First Posted: June 24, 2009
Last Update Posted: June 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
June 23, 2009
June 24, 2009
June 9, 2010
July 2009
December 2009   (Final data collection date for primary outcome measure)
Number of examinations with correctly set threshold algorithm lines [ Time Frame: 1 day ]
Same as current
Complete list of historical versions of study NCT00927303 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Spectralis-Cirrus Study
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
male or femal persons age over 50 years with exudative age-related macular degeneration
Probability Sample
male or female persons aged more than 50 years with exudative age related macular degeneration
Exudative Age Related Macular Degeneration
  • Device: Cirrus-Spectralis
    512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
  • Device: Spectralis-Cirrus
    retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
  • Group 1
    Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2
    Intervention: Device: Cirrus-Spectralis
  • group 2
    intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1
    Intervention: Device: Cirrus-Spectralis
  • group 3
    intervention 2 sequence of observers: 1,2,1,2
    Intervention: Device: Spectralis-Cirrus
  • group 4
    intervention 2 sequence of observers: 2,1,2,1
    Intervention: Device: Spectralis-Cirrus
  • group 5
    intervention 1 sequence of observers 1,1,2,2
    Intervention: Device: Cirrus-Spectralis
  • group 6
    intervention 1 sequence of observers 2,2,1,1
    Intervention: Device: Cirrus-Spectralis
  • group 7
    intervention 2 sequence of observers: 1,1,2,2
    Intervention: Device: Spectralis-Cirrus
  • group 8
    intervention 2 sequence of observers: 2,2,1,1
    Intervention: Device: Spectralis-Cirrus
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00927303
09-086-0609
No
Not Provided
Not Provided
Ilse Krebs, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Not Provided
Study Chair: Susanne Binder, MD, Prof Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
June 2010