Clinical Trial: Trial of the PresView Implant for the Improvement of Near Vision in Patients With Presbyopia

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

Official Title: A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients

Brief Summary: Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses.

Detailed Summary:
Sponsor: Refocus Group, Inc.

Current Primary Outcome: Improvement of Near Visual Acuity [ Time Frame: Greater than or equal to 12 months ]

Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurements.


Original Primary Outcome: Same as current

Current Secondary Outcome: Presence of significant safety events [ Time Frame: Greater than or Equal to 24 months ]

Several indicators of safety are monitored including but not limited to BCDVA, IOP, and chronic inflammation.


Original Secondary Outcome: Same as current

Information By: Refocus Group, Inc.

Dates:
Date Received: July 16, 2010
Date Started: December 2003
Date Completion:
Last Updated: May 4, 2015
Last Verified: May 2015