Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

Not Applicable

Not yet recruiting

• Conditions: Residual Refractive Cylinder; Aphakia; Presbyopia
• Interventions: Device: AcrySof IQ Vivity Extended Vision IOL

• Registration Number: NCT06541795
• Lead Sponsor: Alcon Research

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.

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 Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-07
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL	AcrySof IQ Vivity Extended Vision IOL	AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to Year 3-5 postoperative	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.
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1	Visit 1, Year 3-5 postoperative	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.
Incidence of device deficiencies	Up to Year 3-5 postoperative	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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States