SOLX Gold Shunt for Refractory Glaucoma

February 20, 2017 updated by: SOLX, Inc.

Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma

To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Campinas, Brazil
        • University of Campinas
  • Canada
    • Ontario
      • Vaughan, Ontario, Canada, L4K 0C5
        • Clarity eye Institute
    • Quebec
      • Boisbriand, Quebec, Canada, J7H 1S6
        • Institut de l'Oeil des Laurentides
      • Montreal, Quebec, Canada, H1V 1G5
        • Bellevue Ophthalmology Clinic
  • Israel
      • Tel-Hashomer, Israel, 52621
        • Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Vold Vision, PLLC
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois Eye Institute
    • New York
      • New York, New York, United States, 10003
        • Glaucoma Associates of New York
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Ophthalmic Partners of Pennsylvania
    • Tennessee
      • Maryville, Tennessee, United States, 37803
        • University Eye Surgeons
    • Texas
      • Dallas, Texas, United States, 75231
        • Glaucoma Associates Of Texas
    • Virginia
      • Charlottsville, Virginia, United States, 22908
        • University of Virginia
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54304
        • Memmen, Ltd
  • Venezuela
      • Caracas, Venezuela, 1080-A
        • Centro Medico Docente la Trinidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary open-angle glaucoma
  • age 21 or over
  • refractory glaucoma, with IOP ≥ 24 mmHg on medications and failed prior incisional glaucoma surgery
  • detectable visual field defect (negative MD score)
  • written informed consent
  • available for up to 24 months follow-up

Exclusion Criteria:

  • either eye with VA worse than count fingers
  • angle closure glaucoma episode within past 12 months
  • uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
  • diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma
  • other significant ocular disease, except cataract
  • active ocular infection
  • expected ocular surgery in next 12 months
  • no suitable quadrant for implant
  • systemic corticosteroid therapy > 5 mg/day prednisone
  • intolerance to gonioscopy or other eye exams
  • mental impairment interfering with consent or compliance
  • pregnancy
  • known sensitivity to anticipated medications used at surgery
  • significant co-morbid disease
  • concurrent enrollment in another drug or device study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOLX Gold Shunt
Device: SOLX Gold Shunt
Single use implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Average change in IOP
Time Frame: 1 & 2 years
1 & 2 years
Percentage change in IOP from baseline
Time Frame: 1 & 2 years
1 & 2 years
Average change in number of glaucoma medications
Time Frame: 1 & 2 years
1 & 2 years
Visual acuity changes
Time Frame: 1 & 2 years
1 & 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOLX, Inc.

Investigators

  • Study Director: Nilay Shah, MD, The Emmes Company, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 22, 2011

First Posted (Estimate)

January 25, 2011

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLX84

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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