MedTrace Logo

A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients

NCT01373580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2018-03-29

Study results available
· View outcomes & findings →

Summary

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.

Conditions

Interventions

DEVICE

The Raindrop Near Vision Inlay

The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia

Sponsors & Collaborators

  • ReVision Optics, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven G Slade, M.D.

  • Jon G Dishler, MD

  • John Olkowski, M.D.

  • Dan B Tran, M.D.

  • Ralph Y Chu, M.D.

  • Jeffrey Whitman, M.D.

  • Robert P Lehmann, M.D.

  • Gregory Parkhurst, M.D · Unaffilliated

  • Harvey L Carter, III, M.D. · Unaffilliated

  • Paul Dougherty, M.D. · Unaffilliated

  • John Hovanesian, M.D. · Unaffilliated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

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 NCT01373580 on ClinicalTrials.gov