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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Refocus Group, Inc.

ClinicalTrials.gov Identifier:

NCT01166568

First received: July 16, 2010

Last updated: December 20, 2012

Last verified: December 2012

Purpose

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

Condition	Intervention
Presbyopia	Device: PresVIEW Scleral Implants

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients

Further study details as provided by Refocus Group, Inc.:

Primary Outcome Measures:

Improvement of Near Visual Acuity [ Time Frame: Greater than or equal to 12 months ] [ Designated as safety issue: No ]
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurements.

Secondary Outcome Measures:

Presence of significant safety events [ Time Frame: Greater than or Equal to 24 months ] [ Designated as safety issue: Yes ]
Several indicators of safety are monitored including but not limited to BCDVA, IOP, and chronic inflammation.

Estimated Enrollment:	360
Study Start Date:	December 2003
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PresVIEW Implantation Subjects have PresView Scleral Implants surgical placed in the eye	Device: PresVIEW Scleral Implants Subjects are implanted with the PresView Scleral Spacing Implants, and followed for 24 months. Other Name: PresView Scleral Implants

Eligibility

Criteria

Inclusion Criteria:

Subject must be between 50-60 years old
Subject must have a best corrected distance visual acuity of 20/20 or better
Subject must be mentally competent to understand and comply with the requirements of the study.

Exclusion Criteria:

Any previous eye surgeries including cataract, LASIK, or Muscle surgery
Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166568

Locations

United States, California

Beverly Hills, California, United States, 90210
United States, Illinois

Des Plaines, Illinois, United States, 60016

Lombard, Illinois, United States, 60148
United States, Kentucky

Louisville, Kentucky, United States, 40206
United States, Nebraska

Omaha, Nebraska, United States, 68144
United States, New York

Amherst, New York, United States, 14228
United States, North Carolina

Greensboro, North Carolina, United States, 27410
United States, Oklahoma

Tulsa, Oklahoma, United States, 74133
United States, Tennessee

Nashville, Tennessee, United States, 37203
United States, Texas

San Antonio, Texas, United States, 78215

Sponsors and Collaborators

Refocus Group, Inc.

More Information

No publications provided

Responsible Party:	Refocus Group, Inc.
ClinicalTrials.gov Identifier:	NCT01166568 History of Changes
Other Study ID Numbers:	P-277-5
Study First Received:	July 16, 2010
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Refocus Group, Inc.:

Presbyopia
Reading Vision
Near Vision

Additional relevant MeSH terms:

Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013