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: July 25, 2013
Last verified: July 2013
  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

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Additional 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: July 25, 2013
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 April 23, 2014