THREE-YEAR SAFETY AND EFFICACY RESULTS OF A SUPRACILIARY DRAINAGE DEVICE IN PATIENTS WITH OPEN ANGLE GLAUCOMA FROM THE STAR-GLOBAL STUDY
Published 2024 - 28th ESCRS Winter Meeting
Reference: FP78 | Type: Submission | DOI: 10.82333/1yae-kj32
Authors: Burkhard Dick* 1 , Phillipe Denis 2 , Christoph Hirneiß 3 , Ike K Ahmed 4
1Department of Ophthalmology,Ruhr University Hospital,Bochum,Germany, 2Department of Ophthalmology,Hôpital de la Croix-Rousse,Lyon,France, 3Department of Ophthalmology,Klinikum der Universität München,Munich,Germany, 4Ophthalmology and Vision Sciences,University of Toronto,Toronto,Canada
Purpose
Setting
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 5 mm long network of hollow spheres made of soft, flexible silicone.
Methods
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.
Results
Mean baseline diurnal intraocular pressure (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.
Conclusion
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.