Vivity IOL: Emmetropia Compared to Monovision.

NCT05464732 | Completed Results FDA Device

• 1 other identifier: CEP 20-002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Binocular Uncorrected Near (40 cm) Visual Acuity

  The logMAR binocular uncorrected visual acuity at 40 cm will be measured.

  3 months

Study Arms (2)

Monovision then emmetropia

EXPERIMENTAL

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 emmetropia; Device: Vivity IOL monovision

Emmetropia then monovision

EXPERIMENTAL

Subject's vision will be tested with both eyes corrected for emmetropia. Subjects will then be tested correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.

Device: Vivity IOL emmetropia; Device: Vivity IOL monovision

Interventions

Vivity IOL emmetropia DEVICE

The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to bilateral emmetropia.

Emmetropia then monovision; Monovision then emmetropia

Vivity IOL monovision DEVICE

The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to emmetropia in the dominant eye and -0.50 in the non-dominant eye.

Emmetropia then monovision; Monovision then emmetropia

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with any of the following conditions on the eligibility exam may not be enrolled into the trial.
• 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.
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
• Clinically significant corneal dystrophy
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous intraocular surgery.
• Previous corneal refractive surgery (i.e. laser-assisted in situ keratomileusis, photorefractive keratectomy, radial keratotomy).
• Previous keratoplasty
• Severe dry eye
• Pupil abnormalities

Sponsors & Collaborators

• Carolina Eyecare Physicians, LLC: lead
• Science in Vision: collaborator

Study Sites (1)

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Carolina Eyecare Physicians, LLC

hps@cepmd.com

8438813937

Study Officials

• Kerry Solomon

  Carolina Eyecare Physicians, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients all had same treatment, evaluated postoperatively in two scenarios.

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 19, 2022
• Study Start: September 3, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)