Chapter 2 System Overview
Part Number: 0160-6411, Rev A, 02/2019 Page 31 of 314
Software Release: cOS 5.00
the minimum horizontal and vertical spot spacing coupled with maximum pulse energy. All laser-
created corneal incisions met the histological acceptance criteria when compared to manual
surgical incisions histology.
Cadaver eye testing was also conducted to demonstrate qualitatively the intended laser
incisions can effectively cut a verity of tissue types. In this test, laser parameters, such as
horizontal and vertical spot spacing and laser pulse energy, were bracketed to assess the full
capability of the system. All laser-created corneal incisions met the qualitative acceptance
criteria.
2.5 Clinical Summary
The OPTIMEDICA CATALYS® Precision Laser System was clinically evaluated in a prospective,
randomized, non-inferiority trial in which one eye was randomly assigned to receive treatment
with the CATALYS® System, including capsulotomy and laser phacofragmentation, followed by
standard ultrasound phacoemulsification as necessary. The subject's contralateral eye, serving
as the study Control eye, was assigned treatment with the current “gold standard” surgical
technique of continuous curvilinear capsulorrhexis (CCC) and standard ultrasound
phacoemulsification. CATALYS® System treatment times for the combined capsulotomy and
laser phacofragmentation were found to be less than one minute in all subjects. Total procedure
time (defined as the total time the subject was under suction and docked to the system)
averaged just over 5 minutes with a maximum of 14 minutes.
Capsulotomy efficacy was determined by evaluating the accuracy of the laser capsulotomy
compared to CCC surgical Control. The following table shows the difference between the
intended and the actual diameter of the capsulotomy (all subjects treated with the CATALYS®
System) versus capsulorrhexis (Control).
Table 2.1 Difference Between Actual and Intended Diameter
Laser phacofragmentation efficacy was determined by comparison of the CATALYS® System (all
subjects) and surgical Control cohorts' Cumulative Dissipated Energy (CDE) values reported at
the conclusion of the cataract surgery. The CDE values represent the total ultrasound energy
delivered during the phacoemulsification and are detailed in the table below.
Difference from Intended Diameter CATALYS® System Control
Mean (µm) 29 339
Standard Deviation (µm) 26 248
Minimum (µm) 1 23
Maximum (µm) 132 1013
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