Post-Market Clinical Investigation of the Clareon® IOL

NCT ID: NCT03316885

Last Updated: 2023-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-14

Study Completion Date

2021-09-23

Brief Summary

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The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

Detailed Description

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Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).

Conditions

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Cataract Aphakia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clareon IOL

Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system as a replacement of the human crystalline lens during cataract surgery

Group Type EXPERIMENTAL

Clareon® IOL

Intervention Type DEVICE

Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.

Cataract Surgery

Intervention Type PROCEDURE

Routine small incision cataract surgery with unilateral IOL implantation

Interventions

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Clareon® IOL

Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.

Intervention Type DEVICE

Cataract Surgery

Routine small incision cataract surgery with unilateral IOL implantation

Intervention Type PROCEDURE

Other Intervention Names

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Model SY60WF

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with bilateral cataracts
* Planned small incision cataract removal surgery
* Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits

Exclusion Criteria

* Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
* Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
* Pregnant or lactating, current or planned during the course of the study
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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Sr. Clinical Trial Lead, CDMA, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigative Site

Footscray, Victoria, Australia

Site Status

Alcon Investigative Site

Mornington, Victoria, Australia

Site Status

Alcon Investigative Site

Sydney, , Australia

Site Status

Alcon Investigative Site

Brest, Cedex, France

Site Status

Alcon Investigative Site

Lyon, , France

Site Status

Alcon Investigative Site

Paris, , France

Site Status

Alcon Investigative Site

Frankfurt, , Germany

Site Status

Alcon Investigative Site

Heidelberg, , Germany

Site Status

Alcon Investigative Site

Perugia, , Italy

Site Status

Alcon Investigative Site

Pisa, , Italy

Site Status

Alcon Investigative Site

Amsterdam, , Netherlands

Site Status

Alcon Investigative Site

Jerez de la Frontera, Cadiz, Spain

Site Status

Alcon Investigative Site

Alcalá de Henares, , Spain

Site Status

Alcon Investigative Site

Oviedo, , Spain

Site Status

Alcon Investigative Site

San Sebastián, , Spain

Site Status

Alcon Investigative Site

Valencia, , Spain

Site Status

Alcon Investigative Site

Sutton, Carshalton, United Kingdom

Site Status

Alcon Investigative Site

Brighton, , United Kingdom

Site Status

Alcon Investigative Site

London, , United Kingdom

Site Status

Countries

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Australia France Germany Italy Netherlands Spain United Kingdom

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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ILJ466-P003

Identifier Type: -

Identifier Source: org_study_id

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