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

NCT00531141 | Completed

• 1 other identifier: EK 07-078-VK
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

age-related macular degeneration; optical coherence tomography; retinal thickness; exudative age-related macular degeneration

Study Arms (4)

A

examination twice by examiner 1

Other: examination only

B

examination first by examiner 1 thereafter by examiner 2

Other: examination only

C

examination first by examiner 2 thereafter by examiner 1

Other: examination only

D

examination performed twice by examiner 2

Other: examination only

Interventions

examination only OTHER

OCT performed twice

A; B; C; D

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• Age over 50 years
• Age related macular degeneration

You may not qualify if:

• 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

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, A1030, Austria

Location

Related Publications (1)

• Krebs I, Hagen S, Brannath W, Haas P, Womastek I, de Salvo G, Ansari-Shahrezaei S, Binder S. Repeatability and reproducibility of retinal thickness measurements by optical coherence tomography in age-related macular degeneration. Ophthalmology. 2010 Aug;117(8):1577-84. doi: 10.1016/j.ophtha.2010.04.032. Epub 2010 Jun 16.

  PMID: 20557937 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Ilse Krebs, MD

  Rudolf Foundation Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2007
• First Posted: September 18, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 24, 2009

Record last verified: 2009-06

Locations

AU (1)