Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial.

BACKGROUND/AIMS: The current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma. METHODS: This prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication. RESULTS: Mean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (-40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD. CONCLUSION: This first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events. TRIAL REGISTRATION NUMBER: NCT03193736.

A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I).

PURPOSE: To describe the safety and efficacy of a novel, supraciliary, microinvasive glaucoma surgery drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in the study. DESIGN: Prospective, multicenter, interventional, single-arm trial. PARTICIPANTS: Twenty-six patients with primary open-angle glaucoma uncontrolled with 1 or more intraocular pressure (IOP)-lowering medications. METHODS: Using an ab interno approach, 25 eyes were implanted successfully in a stand-alone procedure with a 5-mm long device made of biocompatible STAR material, which is soft and flexible silicone in a microporous, network design. Intraocular pressure, medication use, and other ocular parameters were evaluated before surgery, 1 day, 1 and 2 weeks, and 1, 3, and 6 months after surgery. MAIN OUTCOME MEASURES: Intraocular pressure reduction at 6 months compared with baseline analyzed using a paired t test. Safety evaluation entailed tabulation of the nature and frequency of adverse events. RESULTS: Mean baseline diurnal IOP was 23.2 mmHg (standard error, 0.6 mmHg) using a mean ± standard deviation of 2.0±1.1 IOP-lowering medication classes. During the 6-month follow-up period, mean IOP ranged from 10.0-16.3 mmHg (mean reductions, 6.9-13.2 mmHg or 31.0%-56.8%). Six months after surgery, mean diurnal IOP was 14.2 mmHg (standard error, 0.9 mmHg), equivalent to a reduction of 9.0 mmHg or 39.1% (P < 0.0001). The mean ± standard deviation number of IOP-lowering medications was 0.3±0.7. Of 24 patients seen at 6-month follow-up, 21 (87.5%) were medication-free and 23 (95.8%) achieved a minimum 20% IOP reduction from baseline. There were no serious adverse events related to the device or procedure, and no additional glaucoma surgery was required. Frequently reported events included anterior chamber inflammation (n = 8), IOP elevation (n = 6), of which 1 event was an IOP spike per protocol, visual acuity reduction (n = 3), and hyphema (n = 3), all of which resolved. There was no change to mean central or peripheral corneal endothelial cell density. No device-related adverse events were reported. CONCLUSIONS: The MINIject glaucoma drainage system significantly lowered IOP and eliminated the need for medication in most patients 6 months after surgery when implanted in a standalone procedure. There were no serious ocular adverse events.