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Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients

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.
 
ClinicalTrials.gov Identifier: NCT01933750
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Refocus Ocular Europe, B.V.

Tracking Information
First Submitted Date  ICMJE August 28, 2013
First Posted Date  ICMJE September 2, 2013
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
Near Visual Acuity [ Time Frame: 12 Months ]
Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01933750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
  • Uncorrected Near Visual Acuity [ Time Frame: 12 Months ]
    The percent of patients with a bilateral post-operative uncorrected near visual acuity (UCNVA) at 40 centimeters of .5 (20/40) or better at 12 months
  • Presence of Significant Safety Events [ Time Frame: 24 months ]
    Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
Official Title  ICMJE A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE Device: PresVIEW Device Implantation
Study Arms  ICMJE
  • No Intervention: Randomized/Control
    7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21
  • Experimental: Non-Randomized/Treatment
    Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device
    Intervention: Device: PresVIEW Device Implantation
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2016)
20
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2013)
150
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 45 or older at commencement of study
  • Best Corrected Distance Visual Acuity of .80 (20/25) or better
  • Patients must be alert, mentally competent, and able to comply with clinical study requirements

Exclusion Criteria:

  • Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries France,   Germany,   Spain
 
Administrative Information
NCT Number  ICMJE NCT01933750
Other Study ID Numbers  ICMJE EU-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Refocus Ocular Europe, B.V.
Study Sponsor  ICMJE Refocus Ocular Europe, B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Refocus Ocular Europe, B.V.
Verification Date April 2016

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