Clinical trial NCT01282346: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Glaucoma, Open Angle
Keywords: Glaucoma shunt
Ocular implant
Gold
Trabeculectomy
Lead sponsor: SOLX, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
timeFrame: 1 year
Secondary outcomes:
measure: Average change in IOP
timeFrame: 1 & 2 years
measure: Percentage change in IOP from baseline
timeFrame: 1 & 2 years
measure: Average change in number of glaucoma medications
timeFrame: 1 & 2 years
measure: Visual acuity changes
timeFrame: 1 & 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Springdale
country: United States
facility: Vold Vision, PLLC
state: Arkansas
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Illinois Eye Institute
state: Illinois
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
city: Bala Cynwyd
country: United States
facility: Ophthalmic Partners of Pennsylvania
state: Pennsylvania
city: Maryville
country: United States
facility: University Eye Surgeons
state: Tennessee
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Charlottsville
country: United States
facility: University of Virginia
state: Virginia
city: Green Bay
country: United States
facility: Memmen, Ltd
state: Wisconsin
city: Campinas
country: Brazil
facility: University of Campinas
city: Vaughan
country: Canada
facility: Clarity Eye Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Institut de l'oeil des Laurentides
state: Quebec
city: Montreal
country: Canada
facility: Bellevue Ophthalmology Clinic
state: Quebec
city: Tel-Hashomer
country: Israel
facility: Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)
city: Caracas
country: Venezuela
facility: Centro Medico Docente La Trinidad
Study officials:
affiliation: The Emmes Company, LLC
name: Nilay Shah, MD
role: STUDY_DIRECTOR
References: