Clinical Investigation to evaluate user experience with the CATALYS Precision Laser System cOS 6.0 - CAST-101-OS60

Overview

No summary available.

Registry

who.int

Start Date

May 27, 2020

End Date

May 4, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Minimum 22 years of age
•Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned
•Availability, willingness, sufficient cognitive awareness to comply with examination procedures
•Clear intraocular media other than cataract
•At least 0\.5D of corneal cylinder (measured by Cassini or other keratometer or corneal topographer for which arcuate corneal incisions or use of toric IOL are planned
•Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.

•Any condition in the study eye which, in the Investigator's opinion, would confound the study results.
•Pupil abnormalities (non\-reactive, fixed pupils, or abnormally shaped pupils)
•Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
•Concurrent participation or participation in any other interventional clinical trial during the duration of this clinical study including 30 days prior to study visit
•Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes