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

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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.

Brief Summary:
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses

Condition or disease Intervention/treatment
Presbyopia Device: PresVIEW Device Implantation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2013
Primary Completion Date : March 2016
Study Completion Date : March 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933750


Locations
United Kingdom
Midland Eye
Birmingham, United Kingdom
Sponsors and Collaborators
Refocus Ocular Europe, B.V.

Responsible Party: Refocus Ocular Europe, B.V.
ClinicalTrials.gov Identifier: NCT01933750     History of Changes
Obsolete Identifiers: NCT01910207
Other Study ID Numbers: EU-001
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases