Real-Life Safety And Efficacy Results Of A Supraciliary Drainage Device At 6 Months (Star-Life)
Published 2024 - 42nd Congress of the ESCRS
Reference: FP23.02 | Type: Free paper | DOI: 10.82333/afn2-rr68
Authors: Kaweh Mansouri 1 , Sheng Lim 2 , Swaantje Grisanti 3 , H. Burkhard Dick 4 , Karsten Klabe* 5 , Jan Lübke 6
1Glaucoma Department,University of Colorado Denver,Denver,United States;Swiss Visio Glaucoma Research Center,Montchoisi Clinic,Lausanne,Switzerland, 2St Thomas Hospital,London,United Kingdom, 3Universitätsklinikum Schleswig-Holstein,Lübeck,Germany, 4University Eye Hospital,Knappschaftskrankenhaus,Bochum,Germany, 5Breyer, Kaymak & Klabe Augenchirurgie,Düsseldorf,Germany, 6Universitatsklinikum Freiburg,Freiburg,Germany
Purpose
In a real-life setting, describe the safety and efficacy of a novel, minimally-invasive glaucoma surgery (MIGS) device (MINIject®; iSTAR Medical, Belgium) implanted ab interno into the supraciliary space in glaucoma patients.
Setting
The STAR-LIFE trial is a real-life, observational, multi-centre registry with follow-up until 2 years in patients treated with the MINIject supraciliary MIGS.
Methods
Any adult patient diagnosed with open-angle glaucoma and treated with a MINIject device with CE-Marking, in either a standalone or combined procedure, regardless of the patient’s lens status, could be included in the STAR-LIFE registry. The patient was followed according to the treating surgeon’s standard of care with no medication washout. The primary endpoint was the reporting of unexpected incidents and/or serious reportable incidents, and secondary endpoints included IOP measurements and ocular hypotensive medication use at each follow-up compared with baseline. Results from the first 100 patients who completed 6-month follow-up are reported here.
Results
In the STAR-LIFE trial, 100 patients were followed up until 6 months in 11 sites in Germany, UK, Switzerland and Austria. The mean baseline IOP prior to implantation was 21.6±8.2 mmHg using a mean of 2.8±1.2 IOP-lowering medications. At 6-month follow-up (n=100), mean diurnal IOP was 13.6±6.5mmHg (-6.9mmHg, -26.9%; p<0.0001) on 0.9±1.2 medications (-1.9, -70.0%; p<0.0001). At 6 months, 61.0% of patients achieved an IOP reduction of >=20% from baseline, 53.0% achieved an IOP <=18 mmHg, and 56.0% of patients were medication-free. There were no unexpected nor serious reportable incidents.
Conclusions
In a diverse number of centres in the STAR-LIFE study, a meaningful mean IOP reduction of 6.9mmHg was achieved 6-months after treatment with the MINIject supraciliary MIGS implant. In a real-life setting, patients are often recruited primarily to reduce or eliminate their ocular hypotensive medication burden. At 6-month follow-up, MINIject achieved a significant mean medication reduction of 1.9 classes (70.0%). This supraciliary MIGS procedure offers a valuable bleb-free treatment option for patients with glaucoma.