Visual Outcomes After Vivity Toric IOL Implantation

NCT04675489 | Terminated

• 1 other identifier: 20-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Assessment

Keywords

Vivity; Extended Vision Toric Intraocular Lens; Patient satisfaction and visual outcomes

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Residual refractive cylinder

  4 months

Study Arms (1)

Vivity Toric IOL

OTHER

Patients with cataract that had phacoemulsification and Vivity Toric IOL implantation.

Other: Procedure: Vivity Toric IOL

Interventions

Procedure: Vivity Toric IOL OTHER

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.

Vivity Toric IOL

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EVP Eye Care: lead
• Alcon Research: collaborator
• Icon Eye Care: collaborator

Study Sites (1)

Icon Eye Care

Grand Junction, Colorado, 81501, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• James Fox, MD

  Icon Eye Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 19, 2020
• Study Start: January 15, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: January 18, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)