Clinical Trial With PRECIZON Presbyopic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-17

Brief Summary

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The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.

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Detailed Description

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Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.

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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Intervention arm

Bilateral implantation with PRECIZON Presbyopic intraocular lens

Group Type EXPERIMENTAL

PRECIZON Presbyopic

Intervention Type DEVICE

Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.

Interventions

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PRECIZON Presbyopic

Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.

Intervention Type DEVICE

Other Intervention Names

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PRECIZON Presbyopic Multifocal intraocular lens (MIOL)

Eligibility Criteria

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Inclusion Criteria

* Presbyopic
* Cataract patient or Clear Lens Extraction (CLE) candidate
* Patients wishes to be spectacle independent for near and far vision
* Patient lifestyle and outlook fit with multifocal IOL implantation
* Qualifies for bilateral implantation
* Patient must have a calculated IOL power within the available diopter range
* Expected best corrected visual acuity of 0.5 Snellen decimal or better after IOL implantation.
* No secondary surgical procedure planned during the course of the study
* Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
* Patients must provide written informed consent
* The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be \<1.0 D.

Exclusion Criteria

* Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
* Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
* Endothelial cell count \<1500 cells/mm2
* Amblyopia
* Congenital eye abnormalities
* Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient
* Concurrent participation or participation during the last 30 days in any other clinical trial
* Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes