Visual Performance of Clareon Vivity and PureSee IOL (PURVI2)

OMIQ Research

Status

Enrolling

Conditions

Cataract

Treatments

Device: Phacoemulsification with implantation of an extended depth of focus intraocular lens

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT07165197

VOR2025-HGC-01

Details and patient eligibility

About

This is study to determine the visual performance of patients with age-related cataracts implanted in both eyes with either of two extended depth of focus intraocular lenses, the Clareon Vivity (Alcon Healthcare) or the PureSee (Johnson & Johnson)

Enrollment

80 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of any sex and race aged 50 years or older
Patients undergoing bilateral age-related cataract surgery with a lens opacity grade 3 or higher in the LOCS III grading scale
Willing to receive implantation of an EDOF IOL
Willing to sign the informed consent and attend the study visits

Exclusion criteria

Requirement of a spherical or toric power of the IOL to achieve emmetropia beyond the available range of either of the two lenses
The number of patients included with low astigmatism that require an equivalent to a T2 toric IOL will be capped to 10 patients/group
Irregular astigmatism
Contact lens wear in the previous 3 weeks before biometry
Moderate or severe ocular surface, corneal, macular or optic nerve disease that in opinion of the investigator precludes the desired functional results
History of previous refractive, cornea, retina or glaucoma surgery
Eyes with a clear lens demanding a refractive lens exchange
Amblyopia in any eye
Significant previous ocular trauma
Pregnancy
A systemic condition that, in the opinion of the investigator, precludes the reliable assessments required in the study (i.e., dementia) or participation in the study (i.e., severe mobility problems).