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

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

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00382395

Enrollment

180

Registered

2006-09-29

Start date

2005-11-30

Completion date

2017-07-31

Last updated

2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Glaucoma, Open Angle

Keywords

Glaucoma shunt, Ocular implant, Gold, trabeculectomy

Brief summary

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

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.

Interventions

DEVICESOLX Gold Shunt GMS-plus

Single use implant

DEVICEAhmed FP7 Glaucoma Valve

Single use implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage reduction in IOP at both 12 and 24 months after implant	1 & 2 years

Secondary

Measure	Time frame
Absolute IOP	1 & 2 years
Mean number of glaucoma medications	1 & 2 years
Success rate	1 & 2 years

Countries

Canada, India, Israel, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026