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

N/ACompletedNCT01933750

Refocus Ocular Europe, B.V.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Presbyopia

Interventions

PresVIEW Device ImplantationDEVICE

Eligibility

Sex: ALLMin age: 45 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Midland Eye

Birmingham, United Kingdom

Outcomes

Primary Outcomes

Near Visual Acuity

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

Time frame: 12 Months

Secondary Outcomes

Uncorrected Near Visual Acuity

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

Time frame: 12 Months

Presence of Significant Safety Events

Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.

Time frame: 24 months

Data from ClinicalTrials.gov

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