Visual Performance of Clareon Vivity and PureSee IOL

NCT ID: NCT07165197

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2026-03-31

Brief Summary

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)

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extended depth of focus intraocular lens Clareon Vivity

Group Type: EXPERIMENTAL

Phacoemulsification with implantation of an extended depth of focus intraocular lens

Intervention Type: DEVICE

Comparison of two different Extended depth of focus intraocular lenses

Extended depth of focus intraocular lens PureSee

Group Type: ACTIVE_COMPARATOR

Phacoemulsification with implantation of an extended depth of focus intraocular lens

Intervention Type: DEVICE

Comparison of two different Extended depth of focus intraocular lenses

Interventions

Phacoemulsification with implantation of an extended depth of focus intraocular lens

Comparison of two different Extended depth of focus intraocular lenses

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OMIQ Research

NETWORK

Sponsor Role: lead

Responsible Party

Merce Guarro

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

OMIQ Research

Sant Cugat del Vallès, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Anna Romero, Administration

Role: primary

asdireccio@omiq.es

+34937071936

Other Identifiers

VOR2025-HGC-01

Identifier Type: -

Identifier Source: org_study_id