SOLX Gold Shunt for Refractory Glaucoma

Glaucoma Clinical Trial

Official title:

Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282346
• Other study ID #: SLX84
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: February 20, 2017
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: SOLX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open Angle
• Glaucoma, Open-Angle

Intervention

Device:
• SOLX Gold Shunt
Single use implant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SOLX, Inc.

Countries where clinical trial is conducted

United States,  Venezuela,  Brazil,  Canada,  Israel, 

Outcome

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