SOLX Gold Shunt for Refractory Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma; Glaucoma, Open Angle

• 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

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

Trial Locations

Locations (17)

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

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

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

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

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

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

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

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

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

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

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