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

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00531141
First received: September 15, 2007
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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 Intervention
Macular Degeneration
Other: examination only

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Estimated Enrollment: 200
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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

primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531141

Locations
Austria
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
  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: Susanne Binder Prof, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00531141     History of Changes
Other Study ID Numbers: EK 07-078-VK
Study First Received: September 15, 2007
Last Updated: June 23, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related macular degeneration
optical coherence tomography
retinal thickness
exudative age-related macular degeneration

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

ClinicalTrials.gov processed this record on August 20, 2014