A European Study of the Performance and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-II).

PRECIS In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary MIGS device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. PURPOSE To evaluate the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627, iSTAR Medical SA, Wavre, Belgium) for surgical treatment of primary open angle glaucoma in patients refractory to topical hypotensive medications. METHODS In a prospective, interventional, single-arm, multi-center, European study (STAR-II), MINIject was successfully implanted in a standalone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal intraocular pressure (IOP) ≤ 21▒mmHg and > 5▒mmHg with ≥20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361. RESULTS At the 6-month follow-up, the primary endpoint was met with 75.9% of patients reaching prospectively defined success. Mean IOP was reduced by 40.2% (9.9▒mmHg) to 14.7±6.0▒mmHg at 6 months from 24.6±3.8▒mmHg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% to 1.0±1.3 from 2.9±1.2 at baseline. Furthermore, 79.3% of patients had mean IOP ≤18▒mmHg, 82.8% achieved a ≥20% IOP reduction and 55.2% were medication-free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density. CONCLUSION Ab-interno supraciliary surgical implantation using MINIject DO627 in a standalone procedure significantly lowers IOP by 40% at 6-month follow-up, while reducing the need for IOP-lowering medication.