NCT04495049

Vivity Insight: A Study of Patient Satisfaction and Visual Performance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Research Insight LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Alcon Vivity or Vivity Toric IOL	Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-07-31
• Last updated: 2021-06-03

Locations

3 sites across 1 country: United States