Glaucoma Clinical Trial
Official title:
Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma
Verified date | February 2017 |
Source | SOLX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Campinas | Campinas | |
Canada | Institut de l'oeil des Laurentides | Boisbriand | Quebec |
Canada | Bellevue Ophthalmology Clinic | Montreal | Quebec |
Canada | Clarity Eye Institute | Vaughan | Ontario |
Israel | Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.) | Tel-Hashomer | |
United States | Ophthalmic Partners of Pennsylvania | Bala Cynwyd | Pennsylvania |
United States | University of Alabama | Birmingham | Alabama |
United States | University of Virginia | Charlottsville | Virginia |
United States | Illinois Eye Institute | Chicago | Illinois |
United States | Glaucoma Associates of Texas | Dallas | Texas |
United States | Memmen, Ltd | Green Bay | Wisconsin |
United States | University of California, Irvine | Irvine | California |
United States | University Eye Surgeons | Maryville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | Glaucoma Associates of New York | New York | New York |
United States | Vold Vision, PLLC | Springdale | Arkansas |
Venezuela | Centro Medico Docente La Trinidad | Caracas |
Lead Sponsor | Collaborator |
---|---|
SOLX, Inc. |
United States, Venezuela, Brazil, Canada, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of eyes that achieve an IOP of > 5mmHg and = 21 mmHg, irrespective of medication use | 1 year | ||
Secondary | Average change in IOP | 1 & 2 years | ||
Secondary | Percentage change in IOP from baseline | 1 & 2 years | ||
Secondary | Average change in number of glaucoma medications | 1 & 2 years | ||
Secondary | Visual acuity changes | 1 & 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06000865 -
Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE
|
N/A | |
Recruiting |
NCT06278597 -
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
|
N/A | |
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03274024 -
The Asia Primary Tube Versus Trab (TVT) Study
|
N/A | |
Completed |
NCT04552964 -
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
|
N/A | |
Recruiting |
NCT01957267 -
Functional and Structural Imaging for Glaucoma
|
||
Active, not recruiting |
NCT04624698 -
iStent Inject New Enrollment Post-Approval Study
|
N/A | |
Completed |
NCT04020705 -
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
|
N/A | |
Completed |
NCT03150160 -
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
|
Phase 4 | |
Not yet recruiting |
NCT05581498 -
Glaucoma Exercise as Medicine Study (GEMS).
|
N/A | |
Recruiting |
NCT02921568 -
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
|
N/A | |
Active, not recruiting |
NCT02901730 -
Clinical Study of LPI With Different Laser Wavelengths
|
N/A | |
Completed |
NCT02955849 -
A Trial of China Laser and Surgery Study Glaucoma in Rural China
|
Early Phase 1 | |
Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
Recruiting |
NCT02554214 -
Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device
|
N/A | |
Active, not recruiting |
NCT02390284 -
Stop Retinal Ganglion Cell Dysfunction Study
|
Phase 3 | |
Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Completed |
NCT02520674 -
Glaucoma Screening With Smartphone Ophthalmology
|
N/A | |
Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 |