Zeiss CIRRUS HD-OCT 500, Руководство пользователя

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CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Appendix
C-1
Appendix C: CIRRUS HD-OCT Repeatability
and Reproducibility of Anterior Scan
Measurements
Study 1: Performance of Pachymetry and Anterior Chamber scan measurements in normal corneas
and in subjects with corneal pathology, and performance of Pachymetry in post-LASIK
subjects, 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 in measuring Central Corneal Thickness (CCT), Angle
to Angle Distance (ATA), Anterior Chamber Depth (ACD), and Pachymetry. In addition, the
comparability of these anterior segment measurements to corresponding measurements
from the Visante OCT was also evaluated.
Data Collection
The study enrolled subjects from three population groups. Group 1 consisted of 48 subjects
with normal cornea. Group 2 included 40 subjects, who had previously undergone LASIK.
Group 3 was made up of 49 subjects with corneal pathology. The subjects ranged in age
from 25 to 69 years.
CIRRUS HD-OCT Anterior Chamber scans to measure CCT, ATA, ACD, and Pachymetry scans
were taken in the Normal Cornea and Corneal Pathology groups. For the Post-LASIK group,
only the Pachymetry scans, yielding nine measurement zones, were taken.
Visante OCT Anterior Segment Single scans were taken in the Normal Cornea and Corneal
Pathology groups. Pachymetry scans were taken on each subject in each group. Enhanced
High Resolution Cornea scans were taken only on subjects in the Post-LASIK group.
Inclusion Criteria
The study inclusion criteria required adult males or females who were able and willing to
make the required study visits, give consent and follow study instructions. In addition,
inclusion criteria specific to the particular group were as follows:
Normal Cornea Group
Subjects with normal corneas.
Corneal Pathology group
Subjects who had received a pathological diagnosis in the anterior segment that involved
or affected the cornea. Such diagnoses could have included but was not limited to:
keratoconus, pellucid marginal degeneration, corneal scarring, corneal degeneration,
corneal dystrophy and corneal changes secondary to disease or surgery.