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

NCT ID: NCT04098367

Last Updated: 2022-05-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-07-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphakia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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VIVITY

VIVITY IOL implanted in the eye during cataract surgery

Group Type EXPERIMENTAL

VIVITY

Intervention Type DEVICE

Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction

Cataract surgery

Intervention Type PROCEDURE

Cataract removal by routine small incision surgery

SYMFONY

SYMFONY IOL implanted in the eye during cataract surgery

Group Type ACTIVE_COMPARATOR

SYMFONY

Intervention Type DEVICE

Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed

Cataract surgery

Intervention Type PROCEDURE

Cataract removal by routine small incision surgery

AT LARA

AT LARA implanted in the eye during cataract surgery

Group Type ACTIVE_COMPARATOR

AT LARA

Intervention Type DEVICE

Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction

Cataract surgery

Intervention Type PROCEDURE

Cataract removal by routine small incision surgery

Interventions

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VIVITY

Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction

Intervention Type DEVICE

SYMFONY

Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed

Intervention Type DEVICE

AT LARA

Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction

Intervention Type DEVICE

Cataract surgery

Cataract removal by routine small incision surgery

Intervention Type PROCEDURE

Other Intervention Names

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AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015 TECNIS Symfony® Extended Range of Vision IOL Model ZXR00 AT LARA® extended depth of focus IOL Model 829MP

Eligibility Criteria

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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.

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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigator 8047

Charlestown, New South Wales, Australia

Site Status

Alcon Investigator 6667

Sydney, New South Wales, Australia

Site Status

Alcon Investigator 7678

Sydney, New South Wales, Australia

Site Status

Alcon Investigator 8052

Eastwood, South Australia, Australia

Site Status

Alcon Investigator 7130

Hobart, Tasmania, Australia

Site Status

Alcon Investigator 8010

Essendon, Victoria, Australia

Site Status

Alcon Investigator 7813

Footscray, Victoria, Australia

Site Status

Alcon Investigator 1702

Mornington, Victoria, Australia

Site Status

Alcon Investigator 8051

Murdoch, Western Australia, Australia

Site Status

Alcon Investigator 8056

Auckland, , New Zealand

Site Status

Alcon Investigator 8050

Auckland, , New Zealand

Site Status

Alcon Investigator 3656

Wellington, , New Zealand

Site Status

Countries

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Australia New Zealand

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ILI875-P001

Identifier Type: -

Identifier Source: org_study_id

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