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

Refocus Group

Status: Completed

Conditions: Presbyopia

Treatments: Device: PresVIEW Device Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01933750

EU-001

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Randomized/Control

No Intervention group

Description:

7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21

Non-Randomized/Treatment

Experimental group

Description:

Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device

Treatment:

Device: PresVIEW Device Implantation