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

Completed · Not applicable

Conditions studied: Aphakia, Cataract

In brief

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

Key facts

Study ID

NCT01292629

Run by

Hoya Surgical Optics, Inc.

People needed

125

Starts

2011-02-01

Expected to finish

2012-05-01

Last updated by the study team

2015-03-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Schwartz Laser Eye Center — E. Shea Blvd, Suite C101, Arizona, United States
• Katzen Eye Care and Laser Center — Boynton Beach, Florida, United States
• Center for Excellence in Eye Care — Miami, Florida, United States
• Eye Surgeons of Indiana — Indianapolis, Indiana, United States
• Eye Health Vision Centers — North Dartmouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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