NCT01282346

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
5 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.9 years

First QC Date

January 5, 2011

Last Update Submit

February 20, 2017

Conditions

GlaucomaGlaucoma, Open Angle

Keywords

Glaucoma shuntOcular implantGoldTrabeculectomy

Outcome Measures

Primary Outcomes (1)

  • Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use

    1 year

Secondary Outcomes (4)

  • Average change in IOP

    1 & 2 years

  • Percentage change in IOP from baseline

    1 & 2 years

  • Average change in number of glaucoma medications

    1 & 2 years

  • Visual acuity changes

    1 & 2 years

Study Arms (1)

SOLX Gold Shunt

EXPERIMENTAL
Device: SOLX Gold Shunt

Interventions

SOLX Gold ShuntDEVICE

Single use implant

SOLX Gold Shunt

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Vold Vision, PLLC

Springdale, Arkansas, 72762, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Illinois Eye Institute

Chicago, Illinois, 60616, United States

Location

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

Ophthalmic Partners of Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University Eye Surgeons

Maryville, Tennessee, 37803, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

University of Virginia

Charlottsville, Virginia, 22908, United States

Location

Memmen, Ltd

Green Bay, Wisconsin, 54304, United States

Location

University of Campinas

Campinas, Brazil

Location

Clarity Eye Institute

Vaughan, Ontario, L4K 0C5, Canada

Location

Institut de l'oeil des Laurentides

Boisbriand, Quebec, J7H 1S6, Canada

Location

Bellevue Ophthalmology Clinic

Montreal, Quebec, H1V 1G5, Canada

Location

Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)

Tel Litwinsky, 52621, Israel

Location

Centro Medico Docente La Trinidad

Caracas, 1080-A, Venezuela

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Nilay Shah, MD

    The Emmes Company, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 25, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

BR(1)US(11)VE(1)IL(1)CA(3)