Clinical Investigation of the Clareon® Intraocular Lens (IOL)

NCT03170154 | Completed Results FDA Device

• 1 other identifier: ILJ466-C001
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Mean Absolute IOL Rotation

  Day 0 (operative), Month 6 (postoperative)

• Mean Absolute IOL Misplacement

  Day 0 (operative)

• Mean Absolute IOL Misalignment

  Day 0 (operative), Month 6 (postoperative)

Study Arms (1)

Clareon IOL

EXPERIMENTAL

Clareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery

Device: Clareon aspheric hydrophobic acrylic monofocal IOL

Interventions

Clareon aspheric hydrophobic acrylic monofocal IOL DEVICE

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.

Clareon IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (16)

Alcon Investigative Site

Fresno, California, 93720, United States

Location

Alcon Investigative Site

Sacramento, California, 95815, United States

Location

Alcon Investigative Site

San Leandro, California, 94578, United States

Location

Alcon Investigative Site

Deerfield Beach, Florida, 33064, United States

Location

Alcon Investigative Site

Orland Park, Illinois, 60467, United States

Location

Alcon Investigative Site

Bloomfield Hills, Michigan, 48302, United States

Location

Alcon Investigative Site

Kansas City, Missouri, 64154, United States

Location

Alcon Investigative Site

New York, New York, 10013, United States

Location

Alcon Investigative Site

Poughkeepsie, New York, 12603, United States

Location

Alcon Investigative Site

Elizabeth City, North Carolina, 27909, United States

Location

Alcon Investigative Site

Southern Pines, North Carolina, 28387, United States

Location

Alcon Investigative Site

Florence, South Carolina, 29501, United States

Location

Alcon Investigative Site

Ladson, South Carolina, 29456, United States

Location

Alcon Investigative Site

Austin, Texas, 78731, United States

Location

Alcon Investigative Site

Nacogdoches, Texas, 75965, United States

Location

Alcon Investigative Site

Appleton, Wisconsin, 54914, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Clinical Trial Lead, CDMA Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, CDMA Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 30, 2017
• Study Start: July 25, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: August 3, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)