Post-Market Clinical Investigation of the Clareon® IOL

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 Overview

• Status: Completed
• Conditions: Cataract; Aphakia
• Intervention / Treatment: Device: Clareon® IOL; Procedure: Cataract Surgery

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).

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, 2067
    • Alcon Investigative Site
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Alcon Investigative Site
    • Mornington, Victoria, Australia, 3931
      • Alcon Investigative Site
• France
  • Lyon, France, 69003
    • Alcon Investigative Site
  • Paris, France, 75014
    • Alcon Investigative Site
  • Cedex
    • Brest, Cedex, France, 29609
      • Alcon Investigative Site
• Germany
  • Frankfurt, Germany, 60590
    • Alcon Investigative Site
  • Heidelberg, Germany, 69120
    • Alcon Investigative Site
• Italy
  • Perugia, Italy, 06129
    • Alcon Investigative Site
  • Pisa, Italy, 56124
    • Alcon Investigative Site
• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Alcon Investigative Site
• Spain
  • Alcalá De Henares, Spain, 28805
    • Alcon Investigative Site
  • Oviedo, Spain, 33012
    • Alcon Investigative Site
  • San Sebastián, Spain, 20014
    • Alcon Investigative Site
  • Valencia, Spain, 46015
    • Alcon Investigative Site
  • Cadiz
    • Jerez De La Frontera, Cadiz, Spain, 11408
      • Alcon Investigative Site
• United Kingdom
  • Brighton, United Kingdom, BN2 5BF
    • Alcon Investigative Site
  • London, United Kingdom, EC1V2PD
    • Alcon Investigative Site
  • Carshalton
    • Sutton, Carshalton, United Kingdom, SM5 1AA
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Diagnosed with bilateral cataracts
• Planned small incision cataract removal surgery
• Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits

Key Exclusion Criteria:

• Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
• Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
• Pregnant or lactating, current or planned during the course of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clareon IOL; Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system as a replacement of the human crystalline lens during cataract surgery	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.; Other Names: Model SY60WF; Procedure: Cataract Surgery; Routine small incision cataract surgery with unilateral IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation	Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% [as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014].	Year 1 post-implantation from second eye surgery
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation	VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).	Year 1 post-implantation from second eye surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation	VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 2 post-implantation from second eye surgery
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation	VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 2 post-implantation from second eye surgery
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation	VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 3 post-implantation from second eye surgery
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation	VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 3 post-implantation from second eye surgery
Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye	VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 1 post-implantation from second eye surgery
UCDVA at 1 Year Post-Implantation - Second Implanted Eye	VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 1 post-implantation from second eye surgery
UCDVA at 2 Years Post-Implantation - First Implanted Eye	VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 2 post-implantation from second eye surgery
UCDVA at 2 Years Post-Implantation - Second Implanted Eye	VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 2 post-implantation from second eye surgery
UCDVA at 3 Years Post-Implantation - First Implanted Eye	VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 3 post-implantation from second eye surgery
UCDVA at 3 Years Post-Implantation - Second Implanted Eye	VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.	Year 3 post-implantation from second eye surgery

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, CDMA, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID Numbers: ILJ466-P003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No