A Multi-Centre Study Of A Supraciliary Glaucoma Drainage Device In Patients With Open Angle Glaucoma: 1-Year Follow-Up Results

To describe the safety and efficacy profile of a novel, supraciliary, minimally-invasive glaucoma surgery (MIGS) drainage system, MINIject^® (iSTAR Medical, Wavre, Belgium), in patients with medically-uncontrolled open-angle glaucoma.

The STAR-IV trial is a prospective, multi-centre, interventional, single-arm study at 2 sites in India and Panama.

The MINIject glaucoma implant is a 5mm long network of hollow spheres made of soft, flexible silicone. It is implanted standalone and ab-interno into the supraciliary space to enhance outflow. The MINIject device was implanted into the supraciliary space of 21 eyes in a stand-alone, ab-interno procedure. Intraocular pressure (IOP), medication use, and other ocular parameters were evaluated preoperatively and postoperatively through 24 months, at pre-specified timepoints. The primary endpoint of the study was IOP reduction at 6 months compared to baseline, analyzed with a paired t-test.  Safety evaluation includes the nature and frequency of adverse events. Interim and preliminary study results at 12-months are reported here.

Baseline mean diurnal IOP was 24.2 ±3.2 mmHg using 2.5 ±1.1 IOP-lowering medications. At 6-month follow-up, mean diurnal IOP was reduced by 10.3mmHg (-41.5%) to 14.2mmHg. In 17 patients at 12-month follow-up, mean diurnal IOP was reduced by 9.2 mmHg (-37.0%) from baseline to 15.3±4.1 mmHg at 12 months. Furthermore, mean medication use at 12-months was 1.6 ±1.2, a mean reduction of 0.9 medications from baseline. An IOP ≤18 mmHg was achieved in 70.6% of eyes at 12 months. The most common adverse events were: anterior chamber inflammation, blurred vision, and IOP increase. There was no significant loss of endothelial cell density and no eye exceeded 30% loss from baseline. 

The MINIject implant effectively reduced IOP by 37.0% at 12 months post-operatively, while decreasing the need for medication. This study confirms the potential efficacy of standalone implantation of a MIGS implant into the supraciliary space to reduce IOP and reduce dependency on glaucoma medications up to 12-month follow-up.