Vivity Insight: A Study of Patient Satisfaction and Visual Performance

Completed

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT04495049

Run by

Research Insight LLC

People needed

60

Starts

2020-08-01

Expected to finish

2021-04-30

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.
• Patients who do not meet the refractive endpoints described in the Inclusion Criteria.

Where it is running

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

Full record on ClinicalTrials.gov

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