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SOLX Gold Shunt for Refractory Glaucoma

This study is currently recruiting participants.
Verified December 2012 by SOLX, Inc.
Sponsor:
Information provided by (Responsible Party):
SOLX, Inc.
ClinicalTrials.gov Identifier:
NCT01282346
First received: January 5, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

January 5, 2011
December 3, 2012
January 2011
March 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01282346 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
SOLX Gold Shunt for Refractory Glaucoma
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma
  • Glaucoma, Open Angle
Device: SOLX Gold Shunt
Single use implant
Experimental: SOLX Gold Shunt
Intervention: Device: SOLX Gold Shunt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Howard Kim, MD 781-609-2016 howard@solx.com
Contact: Doug Adams 781-609-2016 doug@solx.com
United States,   Brazil,   Canada,   Israel,   Spain
 
NCT01282346
SLX84
Not Provided
SOLX, Inc.
SOLX, Inc.
Not Provided
Study Director: Nilay Shah, MD The EMMES Corporation
SOLX, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP