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

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PresVIEW Device Implantation
Sponsored by
Refocus Ocular Europe, B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Reading Glasses, Near Vision

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Midland Eye

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Randomized/Control

Non-Randomized/Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
August 28, 2013
Last Updated
April 4, 2016
Sponsor
Refocus Ocular Europe, B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01933750
Brief Title
Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
Official Title
A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Refocus Ocular Europe, B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Reading Glasses, Near Vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized/Control
Arm Type
No Intervention
Arm Description
7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21
Arm Title
Non-Randomized/Treatment
Arm Type
Experimental
Arm Description
Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device
Intervention Type
Device
Intervention Name(s)
PresVIEW Device Implantation
Primary Outcome Measure Information:
Title
Near Visual Acuity
Description
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 Outcome Measure Information:
Title
Uncorrected Near Visual Acuity
Description
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
Title
Presence of Significant Safety Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Midland Eye
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

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

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