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
  Purpose

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.


Condition Intervention Phase
Glaucoma
Glaucoma, Open Angle
Device: SOLX Gold Shunt GMS-plus
Device: Ahmed FP7 Glaucoma Valve
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by SOLX, Inc.:

Primary Outcome Measures:
  • Percentage reduction in IOP at both 12 and 24 months after implant [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: November 2005
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SOLX Gold Shunt
Device: SOLX Gold Shunt GMS-plus
Single use implant
Active Comparator: 2
Control Ahmed FP7 Shunt
Device: Ahmed FP7 Glaucoma Valve
Single use implant

Detailed Description:

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.

  Eligibility

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

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
  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: NCT00382395

Locations
United States, California
North Bay Eye Associates
Petaluma, California, United States, 94954
United States, Colorado
Glaucoma Consultants of Colorado
Littleton, Colorado, United States, 80120
United States, Florida
International Eye Care
Tampa, Florida, United States, 33603
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07103
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
United States, Oklahoma
Eagle Mountain Vision
Tulsa, Oklahoma, United States, 74132
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
University of Tennessee / Hamilton Eye Institute
Memphis, Tennessee, United States, 38163
Canada, Ontario
Credit Valley EyeCare
Mississauga, Ontario, Canada, L5L 1W8
Canada, Quebec
Institut du Glaucome de Montréal
Montréal, Quebec, Canada, H1V 1G5
India
Bombay City Eye Institute & Research Centre
Mumbai, Maharashtra, India, 400 007
Vision Research Foundation / Sankara Nethralaya
Chennai, Tamil Nadu, India, 600 006
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Poland
Military Institute of the Health Services
Warsaw, Poland, 09-909
Sponsors and Collaborators
SOLX, Inc.
Investigators
Study Director: Jan S. Peterson, MS, RAC The EMMES Corporation
  More Information

No publications provided

Responsible Party: Doug Adams, SOLX, Inc.
ClinicalTrials.gov Identifier: NCT00382395     History of Changes
Other Study ID Numbers: SLX53
Study First Received: September 27, 2006
Last Updated: June 7, 2011
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
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014