The Spectralis-Cirrus Study

Completed

• Conditions: Exudative Age Related Macular Degeneration
• Interventions: Device: Cirrus-Spectralis; Device: Spectralis-Cirrus

• Registration Number: NCT00927303
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Brief Summary

Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. This study is conducted to compare the quality of the examinations of to different spectral domain OCT machines concerning the positioning of algorithm lines. Furthermore the reproducibility of the examinations id tested, both machines provide different techniques to guarantee that in repeated examinations the same location is examined.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Study Start: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Exudative 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
group 6	Cirrus-Spectralis	intervention 1 sequence of observers 2,2,1,1
group 4	Spectralis-Cirrus	intervention 2 sequence of observers: 2,1,2,1
group 2	Cirrus-Spectralis	intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1
group 3	Spectralis-Cirrus	intervention 2 sequence of observers: 1,2,1,2
group 8	Spectralis-Cirrus	intervention 2 sequence of observers: 2,2,1,1
group 5	Cirrus-Spectralis	intervention 1 sequence of observers 1,1,2,2
Group 1	Cirrus-Spectralis	Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2
group 7	Spectralis-Cirrus	intervention 2 sequence of observers: 1,1,2,2

Primary Outcome Measures

Name	Time	Method
Number of examinations with correctly set threshold algorithm lines	1 day

Secondary Outcome Measures

Name	Time	Method
Differences of retinal volume	1 day
Differences of mean retinal thickness in the central region	1 day
Distance acuity	1 day
Age	1 day
Classification of the lesion	1 day

Trial Locations

Locations (1)

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