Cataract Clinical Trial
Official title:
A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
Subjects were implanted with the HARMONI® Modular Intraocular Lens System (HMIOL). The eye
with the higher corneal astigmatism (study eye) was assigned to Cohort 1 and received the
HARMONI® Modular Intraocular Lens System with a toric optic. The fellow eye was assigned to
Cohort 2 and received the HARMONI® Modular Intraocular Lens System with a non-toric optic
during primary implantation, which was replaced with the appropriate optic power (toric or
non-toric) during an intraoperative exchange (IOE) procedure. A total of 7 study visits were
planned, including a preoperative visit, operative visits for each eye, and 4 follow-up
visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of
participation for each subject was up to 6 months, which included a Day -90 to Day -0
preoperative period.
Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and
conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided
by ClarVista Medical, Inc. to Alcon Research, LLC.
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