VIVA: Vivity Outcomes in Patients With Early Stage Glaucoma

• Sponsor: Vance Thompson Vision (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04670575
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Cataract; Presbyopia	Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Study Design

• Study Type: Observational
• Anticipated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Vivity Outcomes in Patients With Early Stage Glaucoma
• Anticipated Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL

Outcome Measures

Primary Outcome Measures

1. Uncorrected Distance Visual Acuity [4-6 months]

2. Uncorrected Intermediate Visual Acuity [4-6 months]

3. Uncorrected Near Visual Acuity [4-6 months]

Secondary Outcome Measures

1. Contrast Sensitivity [4-6 months]

   As measured by Pelli Robson Chart

2. Patient Satisfaction and Spectacle Independence Survey Results [4-6 months]

3. Mean Refractive Spherical Equivalent [4-6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108

Sponsors and Collaborators

• Vance Thompson Vision

Investigators

• Principal Investigator: Brian M Shafer, MD, Vance Thompson Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vance Thompson Vision
• ClinicalTrials.gov Identifier: NCT04670575
• Other Study ID Numbers: VIVA
• First Posted: Dec 17, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Vance Thompson Vision: Extended Range of Vision, Intraocular Lens Technology, Glaucoma
• Additional relevant MeSH terms: Glaucoma; Cataract; Presbyopia

Study Results

No Results Posted as of Dec 17, 2020