The Spectralis-Cirrus Study

Exudative Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927303
• Other study ID #: 09-086-0609
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: June 8, 2010
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exudative Age Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Device:
• Cirrus-Spectralis
512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
• Spectralis-Cirrus
retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of examinations with correctly set threshold algorithm lines		1 day	No
Secondary	Differences of mean retinal thickness in the central region		1 day	No
Secondary	Differences of retinal volume		1 day	No
Secondary	Distance acuity		1 day	No
Secondary	Age		1 day	No
Secondary	Classification of the lesion		1 day	No