Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

NCT06541795 | Withdrawn FDA Device

• 1 other identifier: ILI875-I001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aphakia; Presbyopia; Residual Refractive Cylinder

Keywords

Cataracts

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL

EXPERIMENTAL

AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery

Device: AcrySof IQ Vivity Extended Vision IOL

Interventions

AcrySof IQ Vivity Extended Vision IOL DEVICE

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.

Also known as: 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

AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
• Pregnant or nursing at the time of enrollment.
• Childbirth after IOL implantation.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Aphakia; Presbyopia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Clinical Trial Management Operations, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)