Visual Outcomes After Vivity Toric IOL Implantation

Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens

The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.

Study Overview

• Status: Terminated
• Conditions: Refractive Assessment
• Intervention / Treatment: Other: Procedure: Vivity Toric IOL

Detailed Description

To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • ICON Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
• Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
• Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator

Exclusion Criteria:

• Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
• Ocular trauma or zonular weakness/instability
• Diagnosis of glaucoma or high-risk glaucoma suspect
• Previous refractive surgery
• Unreliable preoperative biometry measurements
• Severe dry eye or ocular surface disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vivity Toric IOL; Patients with cataract that had phacoemulsification and Vivity Toric IOL implantation.	Other: Procedure: Vivity Toric IOL; The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular visual acuity at distance	Monocular uncorrected distance visual acuity	4 months
Binocular visual acuity at distance	Binocular uncorrected distance visual acuity	4 months
Monocular best corrected distance visual acuity	Monocular best corrected distance visual acuity	4 months
Binocular best corrected distance visual acuity	Binocular best corrected distance visual acuity	4 months
Monocular best distance-corrected intermediate visual acuity	Monocular best distance-corrected intermediate visual acuity	4 months
Binocular best distance-corrected intermediate visual acuity	Binocular best distance-corrected intermediate visual acuity	4 months
Monocular best distance-corrected near visual acuity	Monocular best distance-corrected near visual acuity	4 months
Binocular best distance-corrected near visual acuity	Binocular best distance-corrected near visual acuity	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual refractive cylinder	Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation.	4 months

Collaborators and Investigators

• Sponsor: EVP Eye Care
• Collaborators: Alcon Research; Icon Eye Care
• Investigators: Principal Investigator: James Fox, MD, ICON Eye Care

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Vivity; Extended Vision Toric Intraocular Lens; Patient satisfaction and visual outcomes
• Other Study ID Numbers: 20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No