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

This study is currently recruiting participants.
Verified August 2013 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: August 30, 2013
Last verified: August 2013
  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
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         
Klinikum der Johannes-Gutenberg-Universitat Not yet recruiting
Mainz, Germany
Principal Investigator: Urs Bossmerbaumer, Dr. Med.         
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: August 30, 2013
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
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014