Vivity Outcomes in Patients With Early Stage Glaucoma

NCT04670575 | Completed

• 1 other identifier: VIVA
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma; Cataract; Presbyopia

Keywords

Extended Range of Vision, Intraocular Lens Technology, Glaucoma

Outcome Measures

Primary Outcomes (3)

• Uncorrected Distance Visual Acuity

  4-6 months

• Uncorrected Intermediate Visual Acuity

  4-6 months

• Uncorrected Near Visual Acuity

  4-6 months

Secondary Outcomes (3)

• Contrast Sensitivity

  4-6 months

• Patient Satisfaction and Spectacle Independence Survey Results

  4-6 months

• Mean Refractive Spherical Equivalent

  4-6 months

Study Arms (1)

Vivity

Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery.

Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Interventions

Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL PROCEDURE

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

Vivity

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early stage glaucoma with cataracts in both eyes who are planned to have bilateral cataract surgery with implantation of Vivity or Vivity Toric intraocular lens.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Glaucoma; Cataract; Presbyopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Brian M Shafer, MD

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)