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

Completed

• Conditions: Macular Degeneration
• Interventions: Other: examination only

• Registration Number: NCT00531141
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-15
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	examination only	examination twice by examiner 1
D	examination only	examination performed twice by examiner 2
B	examination only	examination first by examiner 1 thereafter by examiner 2
C	examination only	examination first by examiner 2 thereafter by examiner 1

Trial Locations

Locations (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery; 🇦🇹 Vienna, Austria