Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

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

2011-02-28

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

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Detailed Description

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This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.

Conditions

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Aphakia 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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Investigational intraocular lens

iSert 251 intraocular lens

Group Type EXPERIMENTAL

iSert 251 intraocular lens

Intervention Type DEVICE

aphakic intraocular lens

Interventions

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iSert 251 intraocular lens

aphakic intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
* Have clear intraocular media
* Have potential Best Corrected Visual Acuity of 20/40 or better
* Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse

Exclusion Criteria

* Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
* Are monocular
* Have current ocular infection
* Are taking systemic steroids or other anti-metabolites
* Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study

Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No