The Spectralis-Cirrus Study

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status: Completed

Conditions: Exudative Age Related Macular Degeneration

Treatments: Device: Spectralis-Cirrus; Device: Cirrus-Spectralis

Study type: Observational

Funder types: Other

Identifiers

NCT00927303

09-086-0609

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 8 patient groups

Group 1

Description:

Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2

Treatment:

Device: Cirrus-Spectralis

group 2

Description:

intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1

Treatment:

Device: Cirrus-Spectralis

group 3

Description:

intervention 2 sequence of observers: 1,2,1,2

Treatment:

Device: Spectralis-Cirrus

group 4

Description:

intervention 2 sequence of observers: 2,1,2,1

Treatment:

Device: Spectralis-Cirrus

group 5

Description:

intervention 1 sequence of observers 1,1,2,2

Treatment:

Device: Cirrus-Spectralis

group 6

Description:

intervention 1 sequence of observers 2,2,1,1

Treatment:

Device: Cirrus-Spectralis

group 7

Description:

intervention 2 sequence of observers: 1,1,2,2

Treatment:

Device: Spectralis-Cirrus

group 8

Description:

intervention 2 sequence of observers: 2,2,1,1

Treatment:

Device: Spectralis-Cirrus