The Spectralis-Cirrus Study

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines

Conditions
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Exudative Age Related Macular Degeneration

Intervention / Treatment
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* Device: Cirrus-Spectralis
* Device: Spectralis-Cirrus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2 | Device: Cirrus-Spectralis<br>* 512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter<br>|
| group 2<br>intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1 | Device: Cirrus-Spectralis<br>* 512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter<br>|
| group 3<br>intervention 2 sequence of observers: 1,2,1,2 | Device: Spectralis-Cirrus<br>* retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter<br>|
| group 4<br>intervention 2 sequence of observers: 2,1,2,1 | Device: Spectralis-Cirrus<br>* retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter<br>|
| group 5<br>intervention 1 sequence of observers 1,1,2,2 | Device: Cirrus-Spectralis<br>* 512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter<br>|
| group 6<br>intervention 1 sequence of observers 2,2,1,1 | Device: Cirrus-Spectralis<br>* 512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter<br>|
| group 7<br>intervention 2 sequence of observers: 1,1,2,2 | Device: Spectralis-Cirrus<br>* retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter<br>|
| group 8<br>intervention 2 sequence of observers: 2,2,1,1 | Device: Spectralis-Cirrus<br>* retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of examinations with correctly set threshold algorithm lines |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of mean retinal thickness in the central region |  | 1 day | 
| Differences of retinal volume |  | 1 day | 
| Distance acuity |  | 1 day | 
| Age |  | 1 day | 
| Classification of the lesion |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal thickness, threshold algorithm, optical coherence tomography