Vivity Insight: A Study of Patient Satisfaction and Visual Performance

NCT04495049 | Completed

• 1 other identifier: 1911 Vivity ALC57290333
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  8/1/2020 - 7/1/2021

Other Outcomes (2)

• 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.

  8/1/2020 - 7/1/2021

Interventions

Alcon Vivity or Vivity Toric IOL DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing cataract surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (3)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Quentin Allen

Palm City, Florida, 34990, United States

Location

Quantum Vision Center

Edwardsville, Illinois, 62025, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: August 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 3, 2021

Record last verified: 2020-07

Locations

US (3)