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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Refocus Ocular Europe, B.V.
Sponsor:
Information provided by (Responsible Party):
Refocus Ocular Europe, B.V.
ClinicalTrials.gov Identifier:
NCT01933750
First received: August 28, 2013
Last updated: November 4, 2014
Last verified: November 2014
  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 Device Implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients

Further study details as provided by Refocus Ocular Europe, B.V.:

Primary Outcome Measures:
  • Near Visual Acuity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Uncorrected Near Visual Acuity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: PresVIEW Device Implantation

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933750

Contacts
Contact: Selene Burke, O.D. 214-368-0200 sburke@refocus-group.com
Contact: Jason Schmitt, O.D. 214-368-0200 jschmitt@refocus-group.com

Locations
France
Clinique de la Vision Not yet recruiting
Paris, France
Principal Investigator: Dominique Pietrini, M.D.         
Germany
Goethe - University Department of Ophthalmology Not yet recruiting
Frankfurt am Main, Germany
Principal Investigator: Thomas Kohnen, MD, PhD, FEBO         
Spain
Area Oftalmologica Avanzada Not yet recruiting
Barcelona, Spain
Principal Investigator: Carlos Verges, MD         
United Kingdom
Midland Eye Recruiting
Birmingham, United Kingdom
Principal Investigator: Sunil Shah, Professor         
Sponsors and Collaborators
Refocus Ocular Europe, B.V.
  More Information

No publications provided

Responsible Party: Refocus Ocular Europe, B.V.
ClinicalTrials.gov Identifier: NCT01933750     History of Changes
Obsolete Identifiers: NCT01910207
Other Study ID Numbers: EU-001
Study First Received: August 28, 2013
Last Updated: November 4, 2014
Health Authority: United Kingdom: National Health Service, Health Research Authority

Keywords provided by Refocus Ocular Europe, B.V.:
Presbyopia
Reading Glasses
Near Vision

Additional relevant MeSH terms:
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 27, 2014