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SOLX Gold Shunt for Refractory Glaucoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SOLX, Inc.
ClinicalTrials.gov Identifier:
NCT01282346
First received: January 5, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Glaucoma
Glaucoma, Open Angle
Device: SOLX Gold Shunt
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma

Resource links provided by NLM:


Further study details as provided by SOLX, Inc.:

Primary Outcome Measures:
  • Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average change in IOP [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
  • Percentage change in IOP from baseline [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
  • Average change in number of glaucoma medications [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
  • Visual acuity changes [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOLX Gold Shunt Device: SOLX Gold Shunt
Single use implant

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282346

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

No publications provided

Responsible Party: SOLX, Inc.
ClinicalTrials.gov Identifier: NCT01282346     History of Changes
Other Study ID Numbers: SLX84
Study First Received: January 5, 2011
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SOLX, Inc.:
Glaucoma shunt
Ocular implant
Gold
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014