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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 16, 2010
Last Updated Date	December 20, 2012
Start Date ^ICMJE	December 2003
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 19, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01166568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 19, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of the PresView Implant for the Improvement of Near Vision in Patients With Presbyopia
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Presbyopia
Intervention ^ICMJE	Device: PresVIEW Scleral Implants Subjects are implanted with the PresView Scleral Spacing Implants, and followed for 24 months. Other Name: PresView Scleral Implants
Study Arm (s)	Experimental: PresVIEW Implantation Subjects have PresView Scleral Implants surgical placed in the eye Intervention: Device: PresVIEW Scleral Implants
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	360
Estimated Completion Date	July 2014
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01166568
Other Study ID Numbers ^ICMJE	P-277-5
Has Data Monitoring Committee	No
Responsible Party	Refocus Group, Inc.
Study Sponsor ^ICMJE	Refocus Group, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Refocus Group, Inc.
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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