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Visual Outcomes After Vivity Toric IOL Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04675489
Recruitment Status : Terminated (Difficulty in recruiting)
First Posted : December 19, 2020
Last Update Posted : January 18, 2022
Sponsor:
Collaborators:
Alcon Research
Icon Eye Care
Information provided by (Responsible Party):
EVP Eye Care

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 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 : January 15, 2021
Actual Primary Completion Date : December 13, 2021
Actual Study Completion Date : December 13, 2021
Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Monocular visual acuity at distance [ Time Frame: 4 months ]
    Monocular uncorrected distance visual acuity

  2. Binocular visual acuity at distance [ Time Frame: 4 months ]
    Binocular uncorrected distance visual acuity

  3. Monocular best corrected distance visual acuity [ Time Frame: 4 months ]
    Monocular best corrected distance visual acuity

  4. Binocular best corrected distance visual acuity [ Time Frame: 4 months ]
    Binocular best corrected distance visual acuity

  5. Monocular best distance-corrected intermediate visual acuity [ Time Frame: 4 months ]
    Monocular best distance-corrected intermediate visual acuity

  6. Binocular best distance-corrected intermediate visual acuity [ Time Frame: 4 months ]
    Binocular best distance-corrected intermediate visual acuity

  7. Monocular best distance-corrected near visual acuity [ Time Frame: 4 months ]
    Monocular best distance-corrected near visual acuity

  8. Binocular best distance-corrected near visual acuity [ Time Frame: 4 months ]
    Binocular best distance-corrected near visual acuity


Secondary Outcome Measures :
  1. Residual refractive cylinder [ Time Frame: 4 months ]
    Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675489


Locations
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United States, Colorado
Icon Eye Care
Grand Junction, Colorado, United States, 81501
Sponsors and Collaborators
EVP Eye Care
Alcon Research
Icon Eye Care
Investigators
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Principal Investigator: James Fox, MD Icon Eye Care
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: EVP Eye Care
ClinicalTrials.gov Identifier: NCT04675489    
Other Study ID Numbers: 20-01
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EVP Eye Care:
Vivity
Extended Vision Toric Intraocular Lens
Patient satisfaction and visual outcomes