Vivity Insight: A Study of Patient Satisfaction and Visual Performance

This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Alcon Vivity or Vivity Toric IOL

Detailed Description

Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice.

This study is designed to measure postoperative patient-reported outcomes with this new lens implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this study will be designed to mirror those previous studies using the same instrument.

All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of plano sphere.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
  • Florida
    • Palm City, Florida, United States, 34990
      • Quentin Allen
  • Illinois
    • Edwardsville, Illinois, United States, 62025
      • Quantum Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing cataract surgery.

Description

Inclusion Criteria:

• Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
• Patients implanted with Vivity or Vivity Toric lenses bilaterally within 6 months of the survey administration.
• Patients whose postoperative manifest refraction at the time of the survey is within ± 0.5 D sphere and ≤0.75 D of cylindrical refraction.
• Patients who have given consent to participate in the survey.

Exclusion Criteria:

• Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, the judgement of the investigator, influence the outcome measures of the study.
• Patients with previous refractive surgery within the past 6 months prior to cataract surgery.
• Patients with > grade 1 posterior capsule opacity at their last visit.
• Patients who do not meet the refractive endpoints described in the Inclusion Criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"	Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"	8/1/2020 - 7/1/2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"	Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"	8/1/2020 - 7/1/2021
Percentage of postoperative patients who report that they do not require reading glasses for various activities	Percentage of postoperative patients who report that they do not require reading glasses for various activities (driving, reading, including fine print, seeing computer monitor, watching TV, sports/hobbies when asked "For what types of activities do you need glasses to see (other than sunglasses)?"	8/1/2020 - 7/1/2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"	Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?"	8/1/2020 - 7/1/2021
Percentage of patients who report "very satisfied" or "satisfied" to the same question.	Percentage of patients who report "very satisfied" or "satisfied" to the same question.	8/1/2020 - 7/1/2021

Collaborators and Investigators

• Sponsor: Research Insight LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1911 Vivity ALC57290333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No