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Vivity Outcomes in Patients With Early Stage Glaucoma

Vivity Outcomes in Patients With Early Stage Glaucoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04670575
Acronym
VIVA
Enrollment
27
Registered
2020-12-17
Start date
2021-01-01
Completion date
2022-11-30
Last updated
2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma, Presbyopia

Keywords

Extended Range of Vision, Intraocular Lens Technology, Glaucoma

Brief summary

The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).

Interventions

PROCEDURECataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL

Sponsors

Vance Thompson Vision
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum

Inclusion criteria

1. Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS) 2. Subjects with documented diagnosis of pre-perimetric glaucoma 3. Calculated lens power within Vivity/Vivity toric range 4. Willing and able to comprehend informed consent and complete 4-6 month post-op visit 5. Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Exclusion criteria

1. Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA 2. Previous ocular surgery including refractive surgery 3. Subjects who are pregnant or plan to become pregnant during the course of the study.

Design outcomes

Primary

MeasureTime frame
Uncorrected Distance Visual Acuity4-6 months
Uncorrected Intermediate Visual Acuity4-6 months
Uncorrected Near Visual Acuity4-6 months

Secondary

MeasureTime frameDescription
Contrast Sensitivity4-6 monthsAs measured by Pelli Robson Chart
Patient Satisfaction and Spectacle Independence Survey Results4-6 months
Mean Refractive Spherical Equivalent4-6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026