Vivity Outcomes in Patients With Early Stage Glaucoma

Cataract Clinical Trial

— VIVA  

Official title:

Vivity Outcomes in Patients With Early Stage Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04670575
• Other study ID #: VIVA
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2024
• Source: Vance Thompson Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Presbyopia

Intervention

Procedure:
• Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL
Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Vance Thompson Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Distance Visual Acuity		4-6 months
Primary	Uncorrected Intermediate Visual Acuity		4-6 months
Primary	Uncorrected Near Visual Acuity		4-6 months
Secondary	Contrast Sensitivity	As measured by Pelli Robson Chart	4-6 months
Secondary	Patient Satisfaction and Spectacle Independence Survey Results		4-6 months
Secondary	Mean Refractive Spherical Equivalent		4-6 months