Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2018-11-30

Brief Summary

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The purpose of this study is to confirm the effectiveness of the investigational lens in a Korean population, especially for visual performance, quality of vision, and subject satisfaction with the visual outcome, as well as the safety of the lens. This trial will be conducted in Korea.

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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 9 study visits over a 4-5-month period. Of these 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 3 visit (Day 90-120 post second eye implantation). The second eye implantation will occur 2-30 days after the first implantation.

Conditions

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Cataract Presbyopia

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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Multifocal IOL

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag following cataract removal. Both eyes will be implanted.

Group Type EXPERIMENTAL

AcrySof IQ PanOptix Multifocal IOL

Intervention Type DEVICE

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision intended for long-term use over the lifetime of the cataract subject

Interventions

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AcrySof IQ PanOptix Multifocal IOL

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision intended for long-term use over the lifetime of the cataract subject

Intervention Type DEVICE

Other Intervention Names

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Model TFNT00 AcrySof® IQ PanOptix™

Eligibility Criteria

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Inclusion Criteria

* Requires cataract extraction in both eyes
* Clear intraocular media other than cataracts in both eyes
* Calculated lens power between +16.0 and +24.0 diopter (D)
* Preoperative OR expected postoperative regular corneal astigmatism of \< 1.00 D.

Exclusion Criteria

* Pregnant or lactating
* Any clinically significant corneal abnormality, per the Investigator's expert medical opinion
* Previous corneal transplant; previous ocular trauma; previous refractive surgery
* History of, concurrent, or predisposition to retinal conditions, such as diabetic retinopathy, diabetic macular edema, or macular degeneration.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No