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

This study has been completed.
Information provided by (Responsible Party):
Refocus Ocular Europe, B.V. Identifier:
First received: August 28, 2013
Last updated: April 4, 2016
Last verified: April 2016
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses

Condition Intervention
Device: PresVIEW Device Implantation

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
    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 ]
    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.

Enrollment: 20
Study Start Date: February 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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


Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01933750

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

Responsible Party: Refocus Ocular Europe, B.V. Identifier: NCT01933750     History of Changes
Obsolete Identifiers: NCT01910207
Other Study ID Numbers: EU-001
Study First Received: August 28, 2013
Last Updated: April 4, 2016

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

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on May 25, 2017