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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933750

Enrollment

Registered

2013-09-02

Start date

2013-02-28

Completion date

2016-03-31

Last updated

2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

Presbyopia, Reading Glasses, Near Vision

Brief summary

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

Interventions

DEVICEPresVIEW Device Implantation

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026