Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses

The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Study Overview

• Status: Withdrawn
• Conditions: Presbyopia; Aphakia; Residual Refractive Cylinder
• Intervention / Treatment: Device: AcrySof IQ Vivity Extended Vision IOL

Detailed Description

This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.

This study will be conducted in the US and in Spain.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• 22 years old or older at Visit 1.
• Able to understand and sign an approved informed consent form.
• Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
• Documented medical history and required pre-operative baseline information available for retrospective data collection.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
• Pregnant or nursing at the time of enrollment.
• Childbirth after IOL implantation.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL; AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery

Device: AcrySof IQ Vivity Extended Vision IOL; UV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism.; Other Names: AcrySof IQ Vivity Extended Vision IOL: Model DFT015; AcrySof IQ Vivity Extended Vision UV Absorbing IOL: Model DAT015; AcrySof IQ Vivity Toric Extended Vision IOL: Models DFT215, DFT315, DFT415, DFT515 and DFT615 according to country of conduct; AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOL: Models DAT315, DAT415, DAT515 and DAT615 according to country of conduct

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1	Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint.	Visit 1, Year 3-5 postoperative
Incidence of adverse events	An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded.	Up to Year 3-5 postoperative
Incidence of device deficiencies	A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded.	Up to Year 3-5 postoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cataracts
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Cataract; Presbyopia; Aphakia
• Other Study ID Numbers: ILI875-I001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes