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The Spectralis-Cirrus Study

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00927303
First received: June 23, 2009
Last updated: June 8, 2010
Last verified: June 2010

June 23, 2009
June 8, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Differences of retinal volume [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Distance acuity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Age [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Classification of the lesion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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. Print 2011 Aug.

*   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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00927303
09-086-0609
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP