Visual Outcomes After Vivity Toric IOL Implantation

EVP Eye Care4 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Refractive Assessment

Interventions

Procedure: Vivity Toric IOLOTHER

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.

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Icon Eye Care

Grand Junction, Colorado, United States

Outcomes

Primary Outcomes

Monocular visual acuity at distance

Monocular uncorrected distance visual acuity

Time frame: 4 months

Binocular visual acuity at distance

Binocular uncorrected distance visual acuity

Time frame: 4 months

Monocular best corrected distance visual acuity

Time frame: 4 months

Binocular best corrected distance visual acuity

Time frame: 4 months

Monocular best distance-corrected intermediate visual acuity

Time frame: 4 months

Binocular best distance-corrected intermediate visual acuity

Time frame: 4 months

Monocular best distance-corrected near visual acuity

Time frame: 4 months

Binocular best distance-corrected near visual acuity

Time frame: 4 months

Secondary Outcomes

Residual refractive cylinder

Data from ClinicalTrials.gov

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