SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by SOLX, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
SOLX, Inc.
ClinicalTrials.gov Identifier:
NCT00382395
First received: September 27, 2006
Last updated: June 7, 2011
Last verified: June 2011

September 27, 2006
June 7, 2011
November 2005
July 2012   (final data collection date for primary outcome measure)
Percentage reduction in IOP at both 12 and 24 months after implant [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
Percentage reduction in IOP at both six and twelve months after implant
Complete list of historical versions of study NCT00382395 on ClinicalTrials.gov Archive Site
  • Absolute IOP [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
  • Mean number of glaucoma medications [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
  • Success rate [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
  • Absolute IOP
  • Mean number of glaucoma medications
  • Success rate
Not Provided
Not Provided
 
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments

Study Objective:

To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma
  • Glaucoma, Open Angle
  • Device: SOLX Gold Shunt GMS-plus
    Single use implant
  • Device: Ahmed FP7 Glaucoma Valve
    Single use implant
  • Experimental: 1
    SOLX Gold Shunt
    Intervention: Device: SOLX Gold Shunt GMS-plus
  • Active Comparator: 2
    Control Ahmed FP7 Shunt
    Intervention: Device: Ahmed FP7 Glaucoma Valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • either eye with VA worse than count fingers
  • recent angle closure glaucoma episode
  • uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular 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 information is only displayed when the study is recruiting subjects
India,   Israel,   Canada,   United States,   Poland
 
NCT00382395
SLX53
No
Doug Adams, SOLX, Inc.
SOLX, Inc.
Not Provided
Study Director: Jan S. Peterson, MS, RAC The EMMES Corporation
SOLX, Inc.
June 2011

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