Contralateral Claims Study of Clareon Vivity Pro

The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia; Aphakia
• Intervention / Treatment: Device: Clareon Vivity Pro IOL; Device: Clareon Vivity IOL; Procedure: Cataract Surgery; Device: TECNIS PureSee IOL

Detailed Description

Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.

This study will be conducted in Australia and the Philippines.

• Study Type: Interventional
• Enrollment (Estimated): 231
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: alcon.medinfo@alcon.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Cataracts in both eyes.
• Preoperative corneal astigmatism of less than 1.00 diopter (D) in each eye.
• Potential postoperative best corrected visual acuity (BCDVA) of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Desires monovision correction.
• Predicted post-operative residual astigmatism of more than 1D in either eye.
• Any ocular or systemic co-morbidity that, in the investigator's medical opinion, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B); Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized	Device: Clareon Vivity Pro IOL; Investigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.; Device: Clareon Vivity IOL; Currently marketed UV-absorbing, BLF, foldable IOL that provides an extended range of vision from distance to functional near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.; Procedure: Cataract Surgery; Removal of the cloudy lens, followed by implantation of the IOL
Other: Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C); Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized	Device: Clareon Vivity Pro IOL; Investigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.; Procedure: Cataract Surgery; Removal of the cloudy lens, followed by implantation of the IOL; Device: TECNIS PureSee IOL; Currently marketed UV absorbing, violet-light filtering IOL for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)	Visual acuity (VA) will be assessed for each eye individually (monocular) 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 will be 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.	Month 1 postoperative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cataract; Eye Surgery; Intermediate Vision
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Cataract; Presbyopia; Aphakia; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Refractive Surgical Procedures; Cataract Extraction
• Other Study ID Numbers: ILI287-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: No