Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

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

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-07

Study Completion Date

2017-06-26

Brief Summary

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The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

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WITHDRAWN PHASE4

Detailed Description

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This study will be conducted in regions where the test article is approved at the time of study start.

Conditions

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Cataract

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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TFNT00

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Group Type EXPERIMENTAL

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Intervention Type DEVICE

Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Interventions

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AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Intervention Type DEVICE

Other Intervention Names

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Model TFNT00

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of 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;

Exclusion Criteria

* Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
* Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
* Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
* Pregnant or lactating;
* Expected to require ocular surgical or retinal laser treatment;

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No