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

R

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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