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Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia

NCT01166568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2018-09-28

Study results available
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Summary

The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.

Conditions

Interventions

DEVICE

PresVIEW Scleral Implants

Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

Sponsors & Collaborators

  • Refocus Group, Inc.

    lead INDUSTRY

Principal Investigators

  • David Schanzlin, M.D. · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166568 on ClinicalTrials.gov