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Status:

SUSPENDED

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

Lead Sponsor:

SOLX, Inc.

Conditions:

Glaucoma

Glaucoma, Open Angle

Eligibility:

All Genders

21+ years

Phase:

PHASE3

Brief Summary

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 i...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2017

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT00382395

Start Date

November 1 2005

End Date

July 1 2017

Last Update

September 18 2015

Active Locations (15)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (15 locations)

1

North Bay Eye Associates

Petaluma, California, United States, 94954

2

Glaucoma Consultants of Colorado

Littleton, Colorado, United States, 80120

3

International Eye Care

Tampa, Florida, United States, 33603

4

Price Vision Group

Indianapolis, Indiana, United States, 46260