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Post-Market Clinical Investigation of the Clareon® IOL

NCT03316885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2023-08-21

Study results available
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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.

Conditions

  • Cataract
  • Aphakia

Interventions

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Trial Lead, CDMA, Surgical · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2019-10-18
Completion
2021-09-23

Countries

  • Australia
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316885 on ClinicalTrials.gov