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

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: PresVIEW Device Implantation

• Registration Number: NCT01933750
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Randomized/Treatment	PresVIEW Device Implantation	Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device

Primary Outcome Measures

Name	Time	Method
Near Visual Acuity	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

Name	Time	Method
Uncorrected Near Visual Acuity	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	24 months	Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.

Trial Locations

Locations (1)

Midland Eye; 🇬🇧 Birmingham, United Kingdom