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

NCT ID: NCT01933750

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Randomized/Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-Randomized/Treatment

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

Group Type EXPERIMENTAL

PresVIEW Device Implantation

Intervention Type DEVICE

Interventions

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PresVIEW Device Implantation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Refocus Ocular Europe, B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Midland Eye

Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EU-001

Identifier Type: -

Identifier Source: org_study_id

NCT01910207

Identifier Type: -

Identifier Source: nct_alias

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