SOLX Gold Shunt for Refractory Glaucoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01282346

Enrollment

116

Registered

2011-01-25

Start date

2011-01-31

Completion date

2015-12-31

Last updated

2017-02-23

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

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.

Interventions

DEVICESOLX Gold Shunt

Single use implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use	1 year

Secondary

Measure	Time frame
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

Countries

Brazil, Canada, Israel, United States, Venezuela

Outcome results

None listed

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