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SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

NCT00382395 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-09-18

No results posted yet for this study

Summary

Study Objective:

To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

Conditions

Interventions

DEVICE

SOLX Gold Shunt GMS-plus

Single use implant

DEVICE

Ahmed FP7 Glaucoma Valve

Single use implant

Sponsors & Collaborators

  • SOLX, Inc.

    lead INDUSTRY

Principal Investigators

  • Jan S. Peterson, MS, RAC · The Emmes Company, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States
  • Canada
  • India
  • Israel
  • Poland

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 NCT00382395 on ClinicalTrials.gov