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 evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior
subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally
(in both eyes) with the HMTIOL. 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, including the preoperative period (up to 3 months).
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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