SOLX Gold Shunt for Refractory Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma; Glaucoma, Open Angle
• Interventions: Device: SOLX Gold Shunt

• Registration Number: NCT01282346
• Lead Sponsor: SOLX, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-22
• Study First Posted: 2011-01-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Disposition First Submitted: 2017-02-20
• Disposition First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Disposition First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOLX Gold Shunt	SOLX Gold Shunt	-

Primary Outcome Measures

Name	Time	Method
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use	1 year

Secondary Outcome Measures

Name	Time	Method
Percentage change in IOP from baseline	1 & 2 years
Average change in number of glaucoma medications	1 & 2 years
Average change in IOP	1 & 2 years
Visual acuity changes	1 & 2 years

Trial Locations

Locations (17)

Glaucoma Associates of New York; 🇺🇸 New York, New York, United States

Ophthalmic Partners of Pennsylvania; 🇺🇸 Bala Cynwyd, Pennsylvania, United States

Clarity Eye Institute; 🇨🇦 Vaughan, Ontario, Canada

University of Campinas; 🇧🇷 Campinas, Brazil

Memmen, Ltd; 🇺🇸 Green Bay, Wisconsin, United States

Institut de l'oeil des Laurentides; 🇨🇦 Boisbriand, Quebec, Canada

Bellevue Ophthalmology Clinic; 🇨🇦 Montreal, Quebec, Canada

Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.); 🇮🇱 Tel-Hashomer, Israel

Centro Medico Docente La Trinidad; 🇻🇪 Caracas, Venezuela

University of Virginia; 🇺🇸 Charlottsville, Virginia, United States

Vold Vision, PLLC; 🇺🇸 Springdale, Arkansas, United States

University Eye Surgeons; 🇺🇸 Maryville, Tennessee, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Illinois Eye Institute; 🇺🇸 Chicago, Illinois, United States