European Study Of A Supraciliary Glaucoma Drainage Device In Patients With Open Angle Glaucoma: 2-Year Results

Published 2022 - 40th Congress of the ESCRS

Reference: FPS08.01 | Type: Free paper | DOI: 10.82333/tjh8-9v62

Authors: Burkhard Dick* ¹ , Philippe Denis ² , Christoph Hirneiß ³ , Julián García-Feijóo ⁴ , Florent Aptel ⁵ , Katrin Lorenz ⁶ , Norbert Pfeiffer ⁶

¹University Eye Clinic Bochum,Ruhr University,Bochum,Germany, ²Hôpital de la Croix-Rousse,Department of Ophthalmology,Lyon,France, ³University Hospital,Eye Clinic,Munich,Germany, ⁴Hospital Clinico San Carlos,OFTARED,Madrid,Spain, ⁵CHU de Grenoble-Alpes,Eye Clinic,Grenoble,Switzerland, ⁶Eye Clinic,University Medical Center,Mainz,Germany

Purpose

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

Setting

The STAR-II trial is a prospective, multi-centre, interventional, single-arm study at 8 sites across 3 countries in Europe. MINIject® is a 5 mm long network of hollow spheres made of soft, flexible silicone. It is implanted standalone and ab-interno into the supraciliary space to enhance the physiological uveoscleral outflow.

Methods

The MINIject device was implanted in the supraciliary space of 29 eyes in a stand-alone, ab-interno procedure. The primary endpoint was that at least 60 % of patients achieve success at 6 months after surgery. Success was defined as diurnal intraocular pressure (IOP) ≤ 21 mmHg and > 5 mmHg with a minimum 20 % reduction from baseline, with or without glaucoma medication. Washout was not performed. Secondary endpoints include the mean reduction of IOP and medication use over time until 24 months. Moreover, the safety profile of the implantation procedure and the MINIject device were assessed. Results until 24 months follow-up are reported. ClinicalTrials.gov: NCT03624361

Results

Baseline mean diurnal IOP was 24.6 ±3.8 mmHg using 2.9 ±1.2 IOP-lowering medications. At 6-month follow-up, 75.9 % of patients achieved the definition of success (primary endpoint was met). In 27 patients at 24-month follow-up, the success rate was 78%. Mean diurnal IOP was reduced by 9 mmHg (36.3 %) from baseline to 15.5±5.7 mmHg at 24 months. Furthermore, mean medication use at 24-months was 1.4 ±1.5, a mean reduction of 1.5 medications (52 %) from baseline. IOP ≤18 mmHg was maintained in 74 % of eyes at 24 months. The most common adverse events were: IOP increase, reduced visual acuity and visual field defect. The mean reduction in central endothelial cell density at 24 months was 7 %, with no eye exceeding 30 % loss from baseline.

Conclusions

This supraciliary MIGS device implanted in an ab-interno, standalone procedure effectively reduced IOP by 36.3 % 24 months post-procedure while decreasing the need for medication by half. This study confirms the potential efficacy of standalone implantation of a MIGS implant in the supraciliary space to reduce IOP and reduce dependency on glaucoma medication. A larger Investigational Device Exemption (IDE) study with longer follow-up has been approved by the Food and Drug Administration (FDA) and is enrolling patients.