Clinical Investigation of the Clareon® Intraocular Lens (IOL)

NCT ID: NCT03170154

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2019-02-15

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.

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clareon IOL

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

Group Type: EXPERIMENTAL

Clareon aspheric hydrophobic acrylic monofocal IOL

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Trial Lead, CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Alcon Investigative Site

Fresno, California, United States

Alcon Investigative Site

Sacramento, California, United States

Alcon Investigative Site

San Leandro, California, United States

Alcon Investigative Site

Deerfield Beach, Florida, United States

Alcon Investigative Site

Orland Park, Illinois, United States

Alcon Investigative Site

Bloomfield Hills, Michigan, United States

Alcon Investigative Site

Kansas City, Missouri, United States

Alcon Investigative Site

New York, New York, United States

Alcon Investigative Site

Poughkeepsie, New York, United States

Alcon Investigative Site

Elizabeth City, North Carolina, United States

Alcon Investigative Site

Southern Pines, North Carolina, United States

Alcon Investigative Site

Florence, South Carolina, United States

Alcon Investigative Site

Ladson, South Carolina, United States

Alcon Investigative Site

Austin, Texas, United States

Alcon Investigative Site

Nacogdoches, Texas, United States

Alcon Investigative Site

Appleton, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ILJ466-C001

Identifier Type: -

Identifier Source: org_study_id