Evaluation of Clareon Vivity/Vivity Toric

NCT05852470 | Completed Results FDA Device

• 1 other identifier: ILE632-C002
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 7

Brief Summary

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Conditions

Aphakia

Keywords

Cataract; Intraocular lens

Outcome Measures

Primary Outcomes (2)

• Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

  Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.

  Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

• Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

  Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.

  Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Secondary Outcomes (2)

• Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

  Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

• Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

  Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Study Arms (2)

Clareon Vivity/Vivity Toric

EXPERIMENTAL

Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation

Device: Clareon Vivity/Vivity Toric Extended Vision IOL

Clareon Monofocal/Clareon Toric

ACTIVE COMPARATOR

Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation

Device: Clareon Monofocal/Clareon Toric IOL

Interventions

Clareon Vivity/Vivity Toric Extended Vision IOL DEVICE

Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Also known as: Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, Clareon Vivity™ Extended Vision Hydrophobic IOL, Clareon Vivity™ Toric Extended Vision Hydrophobic IOL

Clareon Vivity/Vivity Toric

Clareon Monofocal/Clareon Toric IOL DEVICE

Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Also known as: SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0), Clareon™ Aspheric Hydrophobic Acrylic IOL, Clareon™ Toric Aspheric Hydrophobic Acrylic IOL

Clareon Monofocal/Clareon Toric

Eligibility Criteria

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

You may qualify if:

• Understand and sign an approved Informed Consent form
• Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.

You may not qualify if:

• History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
• Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
• Clinically significant PCO (posterior capsule opacification) affecting vision.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (7)

Wolstan Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, 80528, United States

Location

Grosinger, Spigelman & Grey Eye Surgeons, P.C.

Bloomfield Hills, Michigan, 48302, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Carolina Eyecare Physicians LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Aphakia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Project Lead, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Surgical CRD

  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: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be masked to the IOLs that have been previously implanted in the subject until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: May 23, 2023
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: February 24, 2026
• Results First Posted: November 5, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)