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Post-Market Clinical Investigation of the Clareon® IOL

Primary Purpose

Cataract, Aphakia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clareon® IOL
Cataract Surgery
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clareon IOL

Arm Description

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

Outcomes

Primary Outcome Measures

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].
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 18, 2017
Last Updated
August 17, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03316885
Brief Title
Post-Market Clinical Investigation of the Clareon® IOL
Official Title
Post-Market Clinical Investigation of the Clareon® IOL
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Aphakia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clareon IOL
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Clareon® IOL
Other Intervention Name(s)
Model SY60WF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
Routine small incision cataract surgery with unilateral IOL implantation
Primary Outcome Measure Information:
Title
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
Description
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].
Time Frame
Year 1 post-implantation from second eye surgery
Title
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
Description
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).
Time Frame
Year 1 post-implantation from second eye surgery
Secondary Outcome Measure Information:
Title
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
Description
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.
Time Frame
Year 2 post-implantation from second eye surgery
Title
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
Description
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.
Time Frame
Year 2 post-implantation from second eye surgery
Title
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
Description
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.
Time Frame
Year 3 post-implantation from second eye surgery
Title
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
Description
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.
Time Frame
Year 3 post-implantation from second eye surgery
Title
Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye
Description
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.
Time Frame
Year 1 post-implantation from second eye surgery
Title
UCDVA at 1 Year Post-Implantation - Second Implanted Eye
Description
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.
Time Frame
Year 1 post-implantation from second eye surgery
Title
UCDVA at 2 Years Post-Implantation - First Implanted Eye
Description
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.
Time Frame
Year 2 post-implantation from second eye surgery
Title
UCDVA at 2 Years Post-Implantation - Second Implanted Eye
Description
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.
Time Frame
Year 2 post-implantation from second eye surgery
Title
UCDVA at 3 Years Post-Implantation - First Implanted Eye
Description
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.
Time Frame
Year 3 post-implantation from second eye surgery
Title
UCDVA at 3 Years Post-Implantation - Second Implanted Eye
Description
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.
Time Frame
Year 3 post-implantation from second eye surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA, Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Alcon Investigative Site
City
Mornington
State/Province
Victoria
ZIP/Postal Code
3931
Country
Australia
Facility Name
Alcon Investigative Site
City
Sydney
ZIP/Postal Code
2067
Country
Australia
Facility Name
Alcon Investigative Site
City
Brest
State/Province
Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Alcon Investigative Site
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Alcon Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Alcon Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Alcon Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Alcon Investigative Site
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Alcon Investigative Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Alcon Investigative Site
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
Alcon Investigative Site
City
Jerez De La Frontera
State/Province
Cadiz
ZIP/Postal Code
11408
Country
Spain
Facility Name
Alcon Investigative Site
City
Alcalá De Henares
ZIP/Postal Code
28805
Country
Spain
Facility Name
Alcon Investigative Site
City
Oviedo
ZIP/Postal Code
33012
Country
Spain
Facility Name
Alcon Investigative Site
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Facility Name
Alcon Investigative Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Alcon Investigative Site
City
Sutton
State/Province
Carshalton
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
Brighton
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
Facility Name
Alcon Investigative Site
City
London
ZIP/Postal Code
EC1V2PD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-Market Clinical Investigation of the Clareon® IOL

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