Vivity Insight: A Study of Patient Satisfaction and Visual Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vivity Outcomes in Patients With Early Stage Glaucoma

NCT04670575

Glaucoma Cataract Presbyopia

COMPLETED

Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

NCT06064916

Pseudophakia

COMPLETED

Visual Outcomes of Vivity in Patients With High Axial Length

NCT05210569

Cataract

COMPLETED

Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

NCT04482439

Cataract

COMPLETED NA

Single-center, Double-arm, Prospective Clinical Trial to Compare Visual Performance of Non-diffractive Extended Vision and Neutral Aspheric Monofocal Intraocular Lenses

NCT04591054

Cataract Presbyopia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alcon Vivity or Vivity Toric IOL

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes