Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

Alcon

Status: Completed

Conditions: Aphakia

Treatments: Procedure: Cataract surgery; Device: SYMFONY; Device: AT LARA; Device: VIVITY

Study type: Interventional

Funder types: Industry

Identifiers

NCT04098367

ILI875-P001

Details and patient eligibility

About

The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

Full description

A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.

Enrollment: 222 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned cataract removal in both eyes.
• Willing and able to complete all required postoperative visits.
• Able to understand, read and write English and willing to sign an approved statement of informed consent.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
• Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
• Ocular trauma or ocular surface disease that would affect study measurements.
• Patients who desire monovision correction.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 3 patient groups

VIVITY

Experimental group

Description:

VIVITY IOL implanted in the eye during cataract surgery

Treatment:

Device: VIVITY

Procedure: Cataract surgery

SYMFONY

Active Comparator group

Description:

SYMFONY IOL implanted in the eye during cataract surgery

Treatment:

Device: SYMFONY

Procedure: Cataract surgery

AT LARA

Active Comparator group

Description:

AT LARA implanted in the eye during cataract surgery

Treatment:

Device: AT LARA

Procedure: Cataract surgery