H40.1 H40.5
Conditions
Interventions
Group 1: Implantation of iStent inject (two trabecular micro-bypass stents) and a suprachoroidal iStent supra stent via a micro incision
Sponsors
Glaukos Corp
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Screening Exam Inclusion Criteria: •Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs) •Primary open-angle glaucoma or pseudoexfoliative glaucoma •C/D ratio = 0.9 •Visual field defects (with mean deviation no worse than – 12db), or nerve abnormality characteristic of glaucoma •Subject on two topical ocular hypotensive medications •Medicated IOP of = 18 mmHg and = 30 mmHg •BCVA 20/80 or better •Normal angle anatomy as determined by gonioscopy •Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair placement of stents •Able and willing to attend scheduled follow-up exams for 24 months postoperatively •Able and willing to provide written informed consent on the approved Informed Consent Form Baseline Exam Inclusion Criteria: •Subject has completed appropriate medication washout •Mean diurnal IOP = 21 mmHg and = 45 mmHg after washout of ocular hypotensive medications
Exclusion criteria
Exclusion criteria: Screening Exam Exclusion Criteria: •Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs) •Prior stent implantation •Prior ALT •Prior SLT within 90 days of screening visit •Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders •Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma •Ineligibility for ocular hypotensive medication washout period as determined by the investigator such as: •visual field status would be placed at risk by washout period •unmedicated IOP after washout period would be expected to exceed upper limit of 45 mmHg •Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis) •Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch’s dystrophy); any guttata •Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability •Corneal opacities or disorders that would inhibit visualization of the nasal angle •Congenital or traumatic cataract •Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition •Elevated episcleral venous pressure such as associated with: oactive thyroid orbitopathy ocavernous sinus fistula oSturge-Weber syndrome oorbital tumors oorbital congestive disease •Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.) •Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis) •Any pathology for which, in the investigator’s judgment, the following would be either at risk or contraindicated: •stent implantation •compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) •Fellow eye BCVA worse than 20/200 •Fellow eye actively enrolled in this trial •Concurrent participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the past 30 days. • Pregant or lactating women Baseline Exam Exclusion Criteria: •Subject did not complete medication washout •Mean IOP 45 mmHg after ocular hypotensive medication washout
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| = 20% Reduction in IOP at Month 12: A subject will be considered a responder if they meet all the criteria for the primary efficacy endpoint defined as: •observed at the Month 12 visit, •12-month mean diurnal IOP reduced by = 20% vs. baseline mean diurnal IOP, •no use of ocular hypotensive medication for = 4 weeks immediately prior to the 12-month visit, •no secondary surgical interventions to control IOP (e.g., laser trabeculoplasty, trabeculectomy, stent, shunt or valve placement) prior to the 12-month visit, and •no postoperative procedure to reposition or remove stents prior to the 12-month visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Month 12 IOP = 18 mmHg: A subject will be considered a responder if they meet all the criteria for the secondary efficacy endpoint defined as: •observed at the Month 12 visit, •12-month mean diurnal IOP = 18 mmHg •no use of ocular hypotensive medication for = 4 weeks immediately prior to the 12-month visit, •no secondary surgical interventions to control IOP (e.g., laser trabeculoplasty, trabeculectomy, stent, shunt or valve placement) prior to the 12-month visit, and •no postoperative procedure to reposition or remove stents prior to the 12-month visit | — |
Countries
Germany, Switzerland
Contacts
Public ContactHarald Fuchs
Glaukos GmbH
Outcome results
None listed