NCT01933750

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

August 28, 2013

Last Update Submit

April 4, 2016

Conditions

Presbyopia

Keywords

PresbyopiaReading GlassesNear Vision

Outcome Measures

Primary Outcomes (1)

  • 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

    12 Months

Secondary Outcomes (2)

  • Uncorrected Near Visual Acuity

    12 Months

  • Presence of Significant Safety Events

    24 months

Study Arms (2)

Randomized/Control

NO INTERVENTION

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

Non-Randomized/Treatment

EXPERIMENTAL

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

Device: PresVIEW Device Implantation

Interventions

PresVIEW Device ImplantationDEVICE
Non-Randomized/Treatment

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midland Eye

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

PresbyopiaMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

GB(1)