A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients

Refocus Ocular Europe, B.V.1 site in 1 country20 target enrollmentFebruary 2013

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: Refocus Ocular Europe, B.V.
Enrollment: 20
Locations: 1
Primary Endpoint: Near Visual Acuity
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

March 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Refocus Ocular Europe, B.V.

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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