Vivity Insight: A Study of Patient Satisfaction and Visual Performance

Cataract Clinical Trial

Official title:

Vivity Insight: A Study of Patient Satisfaction and Visual Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495049
• Other study ID #: 1911 Vivity ALC57290333
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2020
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
United States	Quantum Vision Center	Edwardsville	Illinois
United States	Harvard Eye Associates	Laguna Hills	California
United States	Quentin Allen	Palm City	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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