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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531141
• Other study ID #: EK 07-078-VK
• Status: Completed
• Phase: N/A
• First received: September 15, 2007
• Last updated: June 23, 2009
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2009
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Other:
• examination only
OCT performed twice

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria,