Status:
COMPLETED
Vivity Insight: A Study of Patient Satisfaction and Visual Performance
Lead Sponsor:
Research Insight LLC
Conditions:
Cataract
Eligibility:
All Genders
18+ years
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.
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04495049
Start Date
August 1 2020
End Date
April 30 2021
Last Update
June 3 2021
Active Locations (3)
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1
Harvard Eye Associates
Laguna Hills, California, United States, 92653
2
Quentin Allen
Palm City, Florida, United States, 34990
3
Quantum Vision Center
Edwardsville, Illinois, United States, 62025