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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:
Information provided by (Responsible Party):
Refocus Group, Inc.
ClinicalTrials.gov Identifier:
NCT01166568
First received: July 16, 2010
Last updated: May 4, 2015
Last verified: May 2015

July 16, 2010
May 4, 2015
December 2003
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01166568 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Trial of the PresView Implant for the Improvement of Near Vision in Patients With Presbyopia
A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Presbyopia
Device: PresVIEW Scleral Implants
Subjects are implanted with the PresView Scleral Spacing Implants, and followed for 24 months.
Experimental: PresVIEW Implantation
Subjects have PresView Scleral Implants surgical placed in the eye
Intervention: Device: PresVIEW Scleral Implants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
50 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01166568
P-277-5
No
Not Provided
Not Provided
Refocus Group, Inc.
Refocus Group, Inc.
Not Provided
Not Provided
Refocus Group, Inc.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP