The Optical Coherence Tomography in Age-Related Macular Degeneration Study: The OCT in AMD Study

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)
Overall Status
Completed
CT.gov ID
NCT00531141
Collaborator
(none)
200
1
13
15.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: examination only

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Reproducibility of Retinal Thickness Measurements by Optical Coherence Tomography in Age-Related Macular Degeneration The OCT in AMD Study
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
A

examination twice by examiner 1

Other: examination only
OCT performed twice

B

examination first by examiner 1 thereafter by examiner 2

Other: examination only
OCT performed twice

C

examination first by examiner 2 thereafter by examiner 1

Other: examination only
OCT performed twice

D

examination performed twice by examiner 2

Other: examination only
OCT performed twice

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery Vienna Austria A1030

    Sponsors and Collaborators

    • The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    Investigators

    • Principal Investigator: Ilse Krebs, MD, Rudolf Foundation Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00531141
    Other Study ID Numbers:
    • EK 07-078-VK
    First Posted:
    Sep 18, 2007
    Last Update Posted:
    Jun 24, 2009
    Last Verified:
    Jun 1, 2009

    Study Results

    No Results Posted as of Jun 24, 2009