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SOLX Gold Shunt for Refractory Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282346
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
SOLX, Inc.

January 5, 2011
January 25, 2011
February 23, 2017
January 2011
December 2015   (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 ]
Same as current
Complete list of historical versions of study NCT01282346 on Archive Site
  • Average change in IOP [ Time Frame: 1 & 2 years ]
  • Percentage change in IOP from baseline [ Time Frame: 1 & 2 years ]
  • Average change in number of glaucoma medications [ Time Frame: 1 & 2 years ]
  • Visual acuity changes [ Time Frame: 1 & 2 years ]
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
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
December 2015
December 2015   (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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Israel,   United States,   Venezuela
Not Provided
Not Provided
Not Provided
SOLX, Inc.
SOLX, Inc.
Not Provided
Study Director: Nilay Shah, MD The EMMES Corporation
SOLX, Inc.
February 2017

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