NCT03316885

Post-Market Clinical Investigation of the Clareon® IOL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

Detailed description

Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).

Conditions

• Cataract
• Aphakia

Interventions

Type	Name	Description
DEVICE	Clareon® IOL	Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.
PROCEDURE	Cataract Surgery	Routine small incision cataract surgery with unilateral IOL implantation

Timeline

• Start date: 2018-03-14
• Primary completion: 2019-10-18
• Completion: 2021-09-23
• First posted: 2017-10-20
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

19 sites across 7 countries: Australia, France, Germany, Italy, Netherlands, Spain, United Kingdom