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AcrySof IQ Toric A-Code Post-Market Clinical Study

NCT ID: NCT03350503

Last Updated: 2022-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2021-12-17

Brief Summary

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The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.

Detailed Description

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Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.

Conditions

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Cataract Astigmatism

Keywords

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phacoemulsification intraocular lens vision toric

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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Acrysof IQ Toric A-code IOL

IOL implanted during cataract surgery

Group Type EXPERIMENTAL

AcrySof IQ Toric A-code IOL

Intervention Type DEVICE

Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient

Cataract surgery

Intervention Type PROCEDURE

Removal of cataractous lens and implantation of IOL

Interventions

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AcrySof IQ Toric A-code IOL

Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient

Intervention Type DEVICE

Cataract surgery

Removal of cataractous lens and implantation of IOL

Intervention Type PROCEDURE

Other Intervention Names

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Models SN6AT3, SN6AT4, SN6AT5

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of cataracts with planned cataract removal by phacoemulsification
* Calculated lens power within the available range
* Able to sign informed consent and complete all study visits

Exclusion Criteria

* Eye conditions as specified in the protocol
* Uncontrolled glaucoma
* Pregnancy, current or planned
Minimum Eligible Age

20 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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Expert Clinical Project Lead, CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigative Site

Hiroshima, Hiroshima, Japan

Site Status

Alcon Investigative Site

Hakodate, Hokkaido, Japan

Site Status

Alcon Investigative Site

MiyakonojĊ, Miyazaki, Japan

Site Status

Alcon Investigative Site

Saga, Saga-ken, Japan

Site Status

Countries

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Japan

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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ILV814-P001

Identifier Type: -

Identifier Source: org_study_id