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Clinical Trials/NCT00531141
NCT00531141
Completed
Not Applicable

Reproducibility of Retinal Thickness Measurements by Optical Coherence Tomography in Age-Related Macular Degeneration The OCT in AMD Study

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery1 site in 1 country200 target enrollmentMay 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Macular Degeneration
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Enrollment
200
Locations
1
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the retina by providing cross-sectional scans through the retina. Measurements of the retinal thickness based on automatically set border lines created by threshold algorithm provide information concerning the amount of intraretinal fluid and activity of the lesion. In this study the reproducibility of retinal thickness measurements in patients suffering from age-related macular degeneration performed by two independent examiners of two examinations of the same day but performed in a time interval of at least two hours should be evaluated. Using the macular thickness program of stratus OCT, 6 radial lines through the center of the foveal avascular zone are performed, Differences between the first and second measurement will be investigated by a 95% confidence interval, a Bland-Altman plot (with corresponding regression analysis) and a random effect model with time, examiner and diagnosis as fixed factors. Although threshold algorithm failures and fixation problems are common in age-related macular degeneration evidence of reproducibility and repeatability of maximum retinal thickness is expected.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
June 2008
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Eligibility Criteria

Inclusion Criteria

  • Age over 50 years
  • 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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