SOLX Gold Shunt for Refractory Glaucoma

Status:	Completed
Conditions:	Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	21 - Any
Updated:	4/21/2016
Start Date:	January 2011
End Date:	December 2015

Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma

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.

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

We found this trial at

sites

Yale University

New Haven, Connecticut 6520

(203) 432-4771