Three-Year Safety And Efficacy Results Of A Supraciliary Drainage Device In Patients With Open Angle Glaucoma- 3 Year Results From The Star-Global Study

To describe the 3-year safety and efficacy profile of a novel, supraciliary, minimally-invasive glaucoma surgery (MIGS) device in patients with medically-uncontrolled open-angle glaucoma (OAG).

The STAR studies are prospective, multi-centre, interventional, single-arm studies evaluating the safety and efficacy of a supraciliary MIGS device (MINIject®; iSTAR Medical, Belgium) implanted ab-interno in OAG patients in a standalone procedure. The implant is a 5mm long network of hollow spheres made of soft, flexible silicone.

The STAR-I and STAR-II studies have been completed. Across the studies, patients were treated at 10 sites in Europe, Asia and Central America. Upon study completion, patients who received a MINIject implant were invited to enrol into the STAR-GLOBAL study to continue follow-up from 2 years until 5 years. Patients were then followed at 3, 4, and 5 years post-implantation. Intraocular pressure (IOP) measurements and use of IOP-lowering medications were recorded annually, as well as a safety evaluation including adverse events and measurements of corneal endothelial cell density (ECD). Results from 31 patients who completed 3-year follow-up (57.4% of initial STAR-I and STAR-II cohort who were implanted with MINIject) are presented here.

Mean baseline diurnal IOP prior to MINIject implantation (n=31) was 23.5±3.3 mmHg using a mean of 2.3±1.3 IOP-lowering medications. At 2-year follow-up, mean diurnal IOP was 13.5±4.3mmHg (-10.1mmHg, -42.5%; p<0.0001) with 0.8±1.2 medications. At 3-year follow-up, mean diurnal IOP was 16.0±4.6mmHg (-7.5mmHg, -31.6%; p<0.0001) with 1.1±1.3 medications.  At 3 years, 84% of patients achieved an IOP reduction of >=20% from baseline, an IOP <=18 mmHg was achieved in 77% of patients, and 48% of patients were medication-free. The most common adverse events were: IOP elevation, visual field defect and dry eye. The mean reduction in central endothelial cell density was 9.4%, with 1 patient exceeding 30% loss from baseline at the 3-year follow-up.

In an ethnically diverse cohort of patients, the MINIject supraciliary implant achieved meaningful efficacy and a sustained reduction of hypotensive medications up to 3-years post-implantation. This supraciliary MIGS procedure offers a valuable bleb-free treatment option for patients with glaucoma requiring low target IOPs.