Clinical Investigation of the Clareon® Intraocular Lens (IOL)

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clareon aspheric hydrophobic acrylic monofocal IOL

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:

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clareon IOL

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03170154

First Posted

May 26, 2017

Last Updated

July 9, 2020

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT03170154

Brief Title

Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Official Title

Clinical Investigation of the Clareon® IOL

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 25, 2017 (Actual)

Primary Completion Date

February 15, 2019 (Actual)

Study Completion Date

February 15, 2019 (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

Yes

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

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

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

376 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clareon IOL

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Clareon aspheric hydrophobic acrylic monofocal IOL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative

Description

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.

Time Frame

Month 12 (postoperative)

Title

Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative

Description

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.

Time Frame

Month 12 (postoperative)

Title

Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye

Description

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.

Time Frame

Day 0 (operative), up to Month 12 (postoperative)

Secondary Outcome Measure Information:

Title

Mean Absolute IOL Rotation

Description

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.

Time Frame

Day 0 (operative), Month 6 (postoperative)

Title

Mean Absolute IOL Misplacement

Description

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.

Time Frame

Day 0 (operative)

Title

Mean Absolute IOL Misalignment

Description

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.

Time Frame

Day 0 (operative), Month 6 (postoperative)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

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

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Alcon Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

Alcon Investigative Site

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Alcon Investigative Site

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Alcon Investigative Site

City

Orland Park

State/Province

Illinois

ZIP/Postal Code

60467

Country

United States

Facility Name

Alcon Investigative Site

City

Bloomfield Hills

State/Province

Michigan

ZIP/Postal Code

48302

Country

United States

Facility Name

Alcon Investigative Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64154

Country

United States

Facility Name

Alcon Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10013

Country

United States

Facility Name

Alcon Investigative Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12603

Country

United States

Facility Name

Alcon Investigative Site

City

Elizabeth City

State/Province

North Carolina

ZIP/Postal Code

27909

Country

United States

Facility Name

Alcon Investigative Site

City

Southern Pines

State/Province

North Carolina

ZIP/Postal Code

28387

Country

United States

Facility Name

Alcon Investigative Site

City

Florence

State/Province

South Carolina

ZIP/Postal Code

29501

Country

United States

Facility Name

Alcon Investigative Site

City

Ladson

State/Province

South Carolina

ZIP/Postal Code

29456

Country

United States

Facility Name

Alcon Investigative Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Alcon Investigative Site

City

Nacogdoches

State/Province

Texas

ZIP/Postal Code

75965

Country

United States

Facility Name

Alcon Investigative Site

City

Appleton

State/Province

Wisconsin

ZIP/Postal Code

54914

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Cataract

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial