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Vivity Insight: A Study of Patient Satisfaction and Visual Performance

Sponsored by Research Insight LLC

About this trial

Last updated 4 years ago

Study ID

1911 Vivity ALC57290333

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status