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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

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

Detailed Summary: 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.
Sponsor: Hoya Surgical Optics, Inc.

Current Primary Outcome: Visual Acuity [ Time Frame: 4 to 6 months ]

BEST Spectacle-Correction (ETDRS) Distance Visual Acuity


Original Primary Outcome: Best Spectacle-Corrected (ETDRS) Distance Visual Acuity compared to historical and literature controls [ Time Frame: up to 6 months ]

Current Secondary Outcome: Complications and Adverse Events [ Time Frame: 4 to 6 months ]

Number of Participants with Complications or Adverse Events


Original Secondary Outcome: Complications and Adverse Events comparable to historical and literature controls [ Time Frame: up to 6 months ]

Information By: Hoya Surgical Optics, Inc.

Dates:
Date Received: February 4, 2011
Date Started: February 2011
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015