SOLX Gold Shunt for Refractory Glaucoma

Sponsor

SOLX, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01282346

Collaborator

(none)

116

Enrollment

Locations

Arm

Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma, Open Angle	Device: SOLX Gold Shunt	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SOLX Gold Shunt	Device: SOLX Gold Shunt Single use implant

Arm

Intervention/Treatment

Experimental: SOLX Gold Shunt

Device: SOLX Gold Shunt

Single use implant

Outcome Measures

Primary Outcome Measures

Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use [1 year]

Secondary Outcome Measures

Average change in IOP [1 & 2 years]
Percentage change in IOP from baseline [1 & 2 years]
Average change in number of glaucoma medications [1 & 2 years]
Visual acuity changes [1 & 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35233
2	Vold Vision, PLLC	Springdale	Arkansas	United States	72762
3	University of California, Irvine	Irvine	California	United States	92697
4	Yale University	New Haven	Connecticut	United States	06510
5	Illinois Eye Institute	Chicago	Illinois	United States	60616
6	Glaucoma Associates of New York	New York	New York	United States	10003
7	Ophthalmic Partners of Pennsylvania	Bala Cynwyd	Pennsylvania	United States	19004
8	University Eye Surgeons	Maryville	Tennessee	United States	37803
9	Glaucoma Associates of Texas	Dallas	Texas	United States	75231
10	University of Virginia	Charlottsville	Virginia	United States	22908
11	Memmen, Ltd	Green Bay	Wisconsin	United States	54304
12	University of Campinas	Campinas		Brazil
13	Clarity Eye Institute	Vaughan	Ontario	Canada	L4K 0C5
14	Institut de l'oeil des Laurentides	Boisbriand	Quebec	Canada	J7H 1S6
15	Bellevue Ophthalmology Clinic	Montreal	Quebec	Canada	H1V 1G5
16	Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)	Tel-Hashomer		Israel	52621
17	Centro Medico Docente La Trinidad	Caracas		Venezuela	1080-A