Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

NCT ID: NCT03280108

Last Updated: 2019-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-09-27

Brief Summary

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The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

Detailed Description

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Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multifocal IOL

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).

Group Type EXPERIMENTAL

AcrySof IQ PanOptix Multifocal IOL

Intervention Type DEVICE

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision

Monofocal IOL

AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).

Group Type ACTIVE_COMPARATOR

AcrySof Monofocal IOL

Intervention Type DEVICE

AcrySof Monofocal IOL Model SN60AT for single vision

Interventions

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AcrySof IQ PanOptix Multifocal IOL

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision

Intervention Type DEVICE

AcrySof Monofocal IOL

AcrySof Monofocal IOL Model SN60AT for single vision

Intervention Type DEVICE

Other Intervention Names

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Model TFNT00 AcrySof® IQ PanOptix® Model SN60AT AcrySof®

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
* Clear intraocular media other than cataract in both eyes.
* Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.

Exclusion Criteria

* Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
* Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
* Glaucoma (uncontrolled or controlled with medication)
* Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
* Pregnant or lactating
* Expected to require a second surgical intervention or retinal laser treatment.
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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Alcon Research

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Alcon Investigative Site

Fresno, California, United States

Site Status

Alcon Investigative Site

Mt. Dora, Florida, United States

Site Status

Alcon Investigative Site

Panama City, Florida, United States

Site Status

Alcon Investigative Site

Poughkeepsie, New York, United States

Site Status

Alcon Investigative Site

Mt. Pleasant, South Carolina, United States

Site Status

Alcon Investigative Site

Sioux Falls, South Dakota, United States

Site Status

Alcon Investigative Site

Nashville, Tennessee, United States

Site Status

Alcon Investigative Site

Houston, Texas, United States

Site Status

Alcon Investigative Site

Hurst, Texas, United States

Site Status

Alcon Investigative Site

Nacogdoches, Texas, United States

Site Status

Alcon Investigative Site

Salt Lake City, Utah, United States

Site Status

Alcon Investigative Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

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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ILH297-C001

Identifier Type: -

Identifier Source: org_study_id

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