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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
History of Changes
  Purpose

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.


Condition Intervention
Exudative Age Related Macular Degeneration
 Device: Cirrus-Spectralis
Device: Spectralis-Cirrus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Number of examinations with correctly set threshold algorithm lines [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

male or femal persons age over 50 years with exudative age-related macular degeneration


Estimated Enrollment: 110
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2
 Device: Cirrus-Spectralis
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
 Device: Cirrus-Spectralis
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
 Device: Spectralis-Cirrus
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
group 4
intervention 2 sequence of observers: 2,1,2,1
 Device: Spectralis-Cirrus
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
group 5
intervention 1 sequence of observers 1,1,2,2
 Device: Cirrus-Spectralis
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
 Device: Cirrus-Spectralis
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
 Device: Spectralis-Cirrus
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
group 8
intervention 2 sequence of observers: 2,2,1,1
 Device: Spectralis-Cirrus
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

male or female persons aged more than 50 years with exudative age related macular degeneration

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927303

Locations
Austria
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Study Chair: Susanne Binder, MD, Prof Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
  More Information

No publications provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ilse Krebs, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00927303     History of Changes
Other Study ID Numbers: 09-086-0609
Study First Received: June 23, 2009
Last Updated: June 8, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
retinal thickness
threshold algorithm
optical coherence tomography

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013