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

SOLX

Status and phase

Suspended

Phase 3

Conditions

Glaucoma

Glaucoma, Open Angle

Treatments

Device: Ahmed FP7 Glaucoma Valve

Device: SOLX Gold Shunt GMS-plus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00382395

SLX53

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No 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