Back to resultsSOLX Gold Shunt for Refractory Glaucoma
Primary Purpose
Glaucoma, Glaucoma, Open Angle
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SOLX Gold Shunt
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma shunt, Ocular implant, Gold, Trabeculectomy
Eligibility Criteria
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
Sites / Locations
- University of Alabama
- Vold Vision, PLLC
- University of California, Irvine
- Yale University
- Illinois Eye Institute
- Glaucoma Associates of New York
- Ophthalmic Partners of Pennsylvania
- University Eye Surgeons
- Glaucoma Associates of Texas
- University of Virginia
- Memmen, Ltd
- University of Campinas
- Clarity Eye Institute
- Institut de l'oeil des Laurentides
- Bellevue Ophthalmology Clinic
- Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)
- Centro Medico Docente La Trinidad
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SOLX Gold Shunt
Arm Description
Outcomes
Primary Outcome Measures
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
Secondary Outcome Measures
Average change in IOP
Percentage change in IOP from baseline
Average change in number of glaucoma medications
Visual acuity changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01282346
Brief Title
SOLX Gold Shunt for Refractory Glaucoma
Official Title
Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOLX, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open Angle
Keywords
Glaucoma shunt, Ocular implant, Gold, Trabeculectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOLX Gold Shunt
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SOLX Gold Shunt
Intervention Description
Single use implant
Primary Outcome Measure Information:
Title
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Average change in IOP
Time Frame
1 & 2 years
Title
Percentage change in IOP from baseline
Time Frame
1 & 2 years
Title
Average change in number of glaucoma medications
Time Frame
1 & 2 years
Title
Visual acuity changes
Time Frame
1 & 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay Shah, MD
Organizational Affiliation
The Emmes Company, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Vold Vision, PLLC
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Illinois Eye Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Glaucoma Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Ophthalmic Partners of Pennsylvania
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University Eye Surgeons
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Virginia
City
Charlottsville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Memmen, Ltd
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54304
Country
United States
Facility Name
University of Campinas
City
Campinas
Country
Brazil
Facility Name
Clarity Eye Institute
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4K 0C5
Country
Canada
Facility Name
Institut de l'oeil des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
Bellevue Ophthalmology Clinic
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1G5
Country
Canada
Facility Name
Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Centro Medico Docente La Trinidad
City
Caracas
ZIP/Postal Code
1080-A
Country
Venezuela
12. IPD Sharing Statement
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SOLX Gold Shunt for Refractory Glaucoma
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