SOLX Gold Shunt for Refractory Glaucoma

SOLX

Status: Completed

Conditions: Glaucoma; Glaucoma, Open Angle

Treatments: Device: SOLX Gold Shunt

Study type: Interventional

Funder types: Industry

Identifiers

NCT01282346

SLX84

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

SOLX Gold Shunt

Experimental group

Treatment:

Device: SOLX Gold Shunt