Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Status Completed

Clinical Trial Summary

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Clinical Trial Description

Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL. ;

Study Design

Related Conditions & MeSH terms

Cataract

Clinical Trial Details

NCT number	NCT03170154
Study type	Interventional
Source	Alcon Research
Contact
Status	Completed
Phase	N/A
Start date	July 25, 2017
Completion date	February 15, 2019

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