Vivity IOL: Emmetropia Compared to Monovision.

Carolina Eyecare Physicians, LLC

Status: Completed

Conditions: Presbyopia

Treatments: Device: Vivity IOL monovision; Device: Vivity IOL emmetropia

Study type: Interventional

Funder types: Other

Identifiers

NCT05464732

CEP 20-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Monovision then emmetropia

Experimental group

Description:

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.

Treatment:

Device: Vivity IOL emmetropia

Device: Vivity IOL monovision

Emmetropia then monovision

Experimental group

Description:

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.

Treatment:

Device: Vivity IOL emmetropia

Device: Vivity IOL monovision