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

Hoya

Status

Completed

Conditions

Cataract

Aphakia

Treatments

Device: iSert 251 intraocular lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01292629

2010-N251

Details and patient eligibility

About

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

Full description

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.

Enrollment

125 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.