Visual Outcomes After Vivity Toric IOL Implantation

Sponsor

EVP Eye Care (Other)

Overall Status

Terminated

CT.gov ID

NCT04675489

Collaborator

Alcon Research (Industry), Icon Eye Care (Other)

Enrollment

Location

Arm

10.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractive Assessment	Other: Procedure: Vivity Toric IOL	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular LensSubjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 15, 2021

Actual Primary Completion Date :

Dec 13, 2021

Actual Study Completion Date :

Dec 13, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Monocular visual acuity at distance [4 months]
Monocular uncorrected distance visual acuity
Binocular visual acuity at distance [4 months]
Binocular uncorrected distance visual acuity
Monocular best corrected distance visual acuity [4 months]
Monocular best corrected distance visual acuity
Binocular best corrected distance visual acuity [4 months]
Binocular best corrected distance visual acuity
Monocular best distance-corrected intermediate visual acuity [4 months]
Monocular best distance-corrected intermediate visual acuity
Binocular best distance-corrected intermediate visual acuity [4 months]
Binocular best distance-corrected intermediate visual acuity
Monocular best distance-corrected near visual acuity [4 months]
Monocular best distance-corrected near visual acuity
Binocular best distance-corrected near visual acuity [4 months]
Binocular best distance-corrected near visual acuity

Secondary Outcome Measures

Residual refractive cylinder [4 months]
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icon Eye Care	Grand Junction	Colorado	United States	81501

Sponsors and Collaborators

EVP Eye Care
Alcon Research
Icon Eye Care

Investigators

Principal Investigator: James Fox, MD, Icon Eye Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EVP Eye Care

ClinicalTrials.gov Identifier:

NCT04675489

Other Study ID Numbers:

20-01

First Posted:

Dec 19, 2020

Last Update Posted:

Jan 18, 2022

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by EVP Eye Care

Vivity

Extended Vision Toric Intraocular Lens

Patient satisfaction and visual outcomes

Study Results

No Results Posted as of Jan 18, 2022