Zeiss CIRRUS HD-OCT 500, User Manual

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CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Appendix
C-9
Study 2: Repeatability and reproducibility of Wide Angle to Angle and HD Angle scan measurements
in subjects with glaucoma, including repeatability, reproducibility, and comparison to
Visante
Purpose
A non-significant risk clinical study was conducted to determine the repeatability and
reproducibility of the CIRRUS HD-OCT instrument's measurements of Anterior Chamber
Angle (ACA), Trabecular Iris Space Area (TISA), Angle Opening Distance (AOD) and Scleral
Spur Angle (SSA). Another objective of the study was to evaluate the comparability of
CIRRUS HD-OCT to Visante OCT.
Data Collection
Subjects were examined three CIRRUS HD-OCT Model 5000 (CIRRUS 5000) instruments by
three operators; each operator was assigned to a specific CIRRUS 5000 device. For each
subject, study eye 1 was scanned with three Nasal and three Temporal HD Angle scans on
three CIRRUS 5000 devices. Study eye 2 from each subject was scanned with three Wide
Angle to Angle scans on three CIRRUS 5000 devices. The Visante OCT Model 1000 was
used by one operator only. The measurements taken on the CIRRUS were compared
separately with the corresponding measurements taken on the Visante OCT.
The study enrolled 27 subjects ranging in age from 43 to 77 years; the mean was 62 years.
The study population consisted of glaucoma suspects and those with established
glaucoma. The severity of the disease ranged from mild to severe. All enrolled subjects had
a variety of angle configurations ranging from Grade II to Grade IV as assessed with
gonioscopy by the Shaffer
1
method of angle grading.
Inclusion Criteria
The study inclusion criteria required adult males or females who had been diagnosed with
glaucoma of any severity and type or were glaucoma suspects and who were able and
willing to make the required study visits, give consent and follow study instructions.
Exclusion Criteria
The study exclusion criteria included any condition that rendered the subject unable to
fixate well enough to acquire the images and that the subject's study eye did not have any
active infection of the anterior segment.
Data Analysis
All images were reviewed by the operators that acquired them. Study measurements were
generated by manual placement of software tools (Angle tool; TISA tool) for both CIRRUS
and Visante OCT devices.
1. Shaffer RN. Primary glaucomas. Gonioscopy, ophthalmoscopy,and perimetry. Trans Am.
Acad Ophthalmol Otolaryngol. 1960;64:112-127.