Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Clinical Investigation of the Clareon® IOL

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon aspheric hydrophobic acrylic monofocal IOL

Detailed Description

Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Alcon Investigative Site
    • Sacramento, California, United States, 95815
      • Alcon Investigative Site
    • San Leandro, California, United States, 94578
      • Alcon Investigative Site
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Alcon Investigative Site
  • Illinois
    • Orland Park, Illinois, United States, 60467
      • Alcon Investigative Site
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Alcon Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Alcon Investigative Site
  • New York
    • New York, New York, United States, 10013
      • Alcon Investigative Site
    • Poughkeepsie, New York, United States, 12603
      • Alcon Investigative Site
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
      • Alcon Investigative Site
    • Southern Pines, North Carolina, United States, 28387
      • Alcon Investigative Site
  • South Carolina
    • Florence, South Carolina, United States, 29501
      • Alcon Investigative Site
    • Ladson, South Carolina, United States, 29456
      • Alcon Investigative Site
  • Texas
    • Austin, Texas, United States, 78731
      • Alcon Investigative Site
    • Nacogdoches, Texas, United States, 75965
      • Alcon Investigative Site
  • Wisconsin
    • Appleton, Wisconsin, United States, 54914
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• Planned routine cataract surgery in at least one eye;
• Calculated lens power within the available range;
• Willing and able to sign an informed consent statement;
• Clear intraocular media other than cataract.

Key Exclusion Criteria:

• Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
• Previous corneal surgery;
• Rubella or traumatic cataract;
• Ocular trauma, previous refractive surgery;
• Current or recent use of certain medications as specified in the protocol;
• Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.

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 monofocal IOL implanted in one eye during routine small incision cataract surgery	Device: Clareon aspheric hydrophobic acrylic monofocal IOL; Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative	Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.	Month 12 (postoperative)
Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative	Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.	Month 12 (postoperative)
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye	Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.	Day 0 (operative), up to Month 12 (postoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absolute IOL Rotation	IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.	Day 0 (operative), Month 6 (postoperative)
Mean Absolute IOL Misplacement	IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.	Day 0 (operative)
Mean Absolute IOL Misalignment	IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.	Day 0 (operative), Month 6 (postoperative)

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): July 25, 2017
• Primary Completion (Actual): February 15, 2019
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ILJ466-C001

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: Yes
• product manufactured in and exported from the U.S.: No