Vivity Outcomes in Patients With Early Stage Glaucoma

Completed

• Conditions: Glaucoma; Presbyopia; Cataract
• Interventions: Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

• Registration Number: NCT04670575
• Lead Sponsor: Vance Thompson Vision

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-17
• Study Start: 2021-01-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-11-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vivity	Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL	Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery.

Primary Outcome Measures

Name	Time	Method
Uncorrected Near Visual Acuity	4-6 months
Uncorrected Intermediate Visual Acuity	4-6 months
Uncorrected Distance Visual Acuity	4-6 months

Secondary Outcome Measures

Name	Time	Method
Mean Refractive Spherical Equivalent	4-6 months
Contrast Sensitivity	4-6 months	As measured by Pelli Robson Chart
Patient Satisfaction and Spectacle Independence Survey Results	4-6 months

Trial Locations

Locations (1)

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States