Vivity IOL: Emmetropia Compared to Monovision.

Visual Outcomes, Patient Satisfaction and Spectacle Independence Evaluation of the Acrysof® IQ Vivity® Intraocular Lens Targeted for Emmetropia or Nanovision.

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Different options are available including: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocal, trifocal and extended depth of focus (EDOF) IOLs. The Vivity Extended Vision IOL is not a multifocal IOL but due to its design, it provides better intermediate and near VA compared to a monofocal IOL.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Vivity IOL

Detailed Description

The study is concerned with the visual performance of the Vivity Extended Vision IOL at distance, intermediate and near when one of the eyes is targeted for emmetropia and the other is targeted for slight myopia. Patients will serve as their own controls with visual performance evaluated against corrected vision with a target of emmetropia in both eyes.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must fulfill the following conditions to qualify for enrollment into the trial

1. Subject is undergoing bilateral lens extraction with intraocular lens implantation.
2. Gender: Males and Females.
3. Age: 50 years and older.
4. Willing and able to provide written informed consent for participation in the study
5. Willing and able to comply with scheduled visits and other study procedures.
6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries
7. Subjects who require an IOL power in the range of +15.0 D to +25.0 D only.
8. Subjects who require a toric IOL up to +3.00 D at the IOL plane (2.06 D corneal plane).
9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

Subjects with any of the following conditions on the eligibility exam may not be enrolled into the trial.

1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Contact lens use during the active treatment portion of the trial.
5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
6. Clinically significant corneal dystrophy
7. History of chronic intraocular inflammation.
8. History of retinal detachment.
9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
10. Previous intraocular surgery.
11. Previous corneal refractive surgery (i.e. laser-assisted in situ keratomileusis, photorefractive keratectomy, radial keratotomy).
12. Previous keratoplasty
13. Severe dry eye
14. Pupil abnormalities
15. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
16. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
17. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monovision; The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.	Device: Vivity IOL; The Vivity IOL will be implanted bilaterally in all subjects.
Active Comparator: Emmetropia; Subject's vision will be tested with both eyes corrected for emmetropia.	Device: Vivity IOL; The Vivity IOL will be implanted bilaterally in all subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected near (40 cm) visual acuity	The logMAR binocular uncorrected visual acuity at 40 cm will be measured.	3 months

Collaborators and Investigators

• Sponsor: Carolina Eyecare Physicians, LLC
• Collaborators: Science in Vision
• Investigators: Principal Investigator: Kerry Solomon, Carolina EyeCare Physicians, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CEP 20-002

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: Yes
• product manufactured in and exported from the U.S.: Yes