CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 245 enrolled
Drug / intervention
Clareon® IOL +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03316885
NCT03316885N/ACompleted
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Post-Market Clinical Investigation of the Clareon® IOL

Alcon Research·interventional·Posted Oct 20, 2017·Updated Aug 21, 2023

In Brief

A clinical study evaluating Clareon® IOL and Cataract Surgery for Cataract and Aphakia. Completed, enrolled 245 participants across 19 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract, Aphakia
CountriesAustralia, France, Germany, Italy, Netherlands, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartMar 14, 2018
Primary CompletionOct 18, 2019
Study CompletionSep 23, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.7 years ago

Interventions

Clareon® IOLdevice

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.

Cataract Surgeryprocedure

Routine small incision cataract surgery with unilateral IOL implantation