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

NCT ID: NCT00531141

Last Updated: 2009-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

examination twice by examiner 1

examination only

Intervention Type: OTHER

OCT performed twice

B

examination first by examiner 1 thereafter by examiner 2

examination only

Intervention Type: OTHER

OCT performed twice

C

examination first by examiner 2 thereafter by examiner 1

examination only

Intervention Type: OTHER

OCT performed twice

D

examination performed twice by examiner 2

examination only

Intervention Type: OTHER

OCT performed twice

Interventions

examination only

OCT performed twice

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role: lead

Responsible Party

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Principal Investigators

Ilse Krebs, MD

Role: PRINCIPAL_INVESTIGATOR

Rudolf Foundation Clinic

Locations

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 20557937 (View on PubMed)

Other Identifiers

EK 07-078-VK

Identifier Type: -

Identifier Source: org_study_id