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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01166568
First Posted: July 21, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Refocus Group, Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    Several indicators of safety are monitored including but not limited to BCDVA, IOP, and chronic inflammation.


Enrollment: 360
Study Start Date: December 2003
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Refocus Group, Inc.
ClinicalTrials.gov Identifier: NCT01166568     History of Changes
Other Study ID Numbers: P-277-5
First Submitted: July 16, 2010
First Posted: July 21, 2010
Last Update Posted: October 12, 2017
Last Verified: May 2015

Keywords provided by Refocus Group, Inc.:
Presbyopia
Reading Vision
Near Vision

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases