SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

Study Overview
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Brief Summary
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Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

Detailed Description
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This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.

Official Title
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Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments

Conditions
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Glaucoma, Glaucoma, Open Angle

Intervention / Treatment
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* Device: SOLX Gold Shunt GMS-plus
* Device: Ahmed FP7 Glaucoma Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary open-angle, pseudoexfoliative, or pigmentary glaucoma Age 21 or over refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery detectable visual field defect (negative MD score) written consent available for up to 24 months follow-up Exclusion Criteria: either eye with VA worse than count fingers recent angle closure glaucoma episode uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SOLX Gold Shunt | Device: SOLX Gold Shunt GMS-plus<br>* Single use implant<br>|
| Active Comparator: 2<br>Control Ahmed FP7 Shunt | Device: Ahmed FP7 Glaucoma Valve<br>* Single use implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in IOP at both 12 and 24 months after implant |  | 1 & 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute IOP |  | 1 & 2 years | 
| Mean number of glaucoma medications |  | 1 & 2 years | 
| Success rate |  | 1 & 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma shunt, Ocular implant, Gold, trabeculectomy