ESCRS - FP08.09 - Real-Life Safety And Efficacy Results Of A Supraciliary Drainage Device At 12 Months (Star-Life)

Real-Life Safety And Efficacy Results Of A Supraciliary Drainage Device At 12 Months (Star-Life)

Published 2025 - 43rd Congress of the ESCRS

Reference: FP08.09 | Type: Free paper | DOI: 10.82333/warx-n585

Authors: Umberto Camellin* 1 , Gianluigi Latino 2 , Silvia Rimondi 2 , Gabriele Vizzari 3 , Piero Ceruti 3 , Massimo Camellin 2

1Sekal Microchirurgia Rovigo,Rovigo,Italy;Ophthalmology,Legnago Hospital,Legnago,Italy, 2Sekal Microchirurgia Rovigo,Rovigo,Italy, 3Ophthalmology,Legnago Hospital,Legnago,Italy

Purpose

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 is described in a real-life setting.

Setting

STAR-LIFE is a real-life, observational, multi-centre registry with follow-up until two years in up to 320 adult patients diagnosed with open-angle glaucoma.

Methods

Patients were treated in either a standalone procedure (phakic or pseudophakic) or combined with cataract surgery, and followed according to the 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 intraocular pressure (IOP) measurements and ocular hypotensive medication use (meds) compared with baseline. In 12 sites in Germany, Switzerland, the UK, and Austria, an interim analysis of the first 145 patients with 12-month follow-up was performed. Mild-to-moderate glaucoma was reported in 61.1% of patients.

Results

Mean pre-operative and 12-month IOPs were 21.0±6.7 mmHg on 2.7±1.5 meds and 15.1±6.0mmHg (-5.9mmHg, -23.0%; p<0.0001) on 1.5±1.6 meds (-1.1, -43.4%; p<0.0001) respectively. Furthermore, 53.1% patients had a >=20% IOP reduction, 77.2% had IOP <=18 mmHg, and 42.1% were med-free at 12 months. Outcomes after standalone (84.1%) vs combined-cataract surgery were similar. There were no unexpected nor serious reportable incidents. Serious incidents included: IOP increase (4.1%), hypotony (3.4%), device migration (2.1%), hyphaema (1.4%), and anterior chamber (AC) inflammation, narrow AC, vitreous haemorrhage (all 0.7%). All incidents resolved apart from one IOP increase treated only with meds. Secondary surgery occurred in 7.6% of patients.

Conclusions

In a diverse number of centres in the STAR-LIFE study, a meaningful mean IOP reduction of 5.9mmHg was achieved 12 months after treatment with MINIject, in addition to a mean 1.1 medication reduction. This supraciliary MIGS procedure offers a valuable bleb-free treatment option for patients with glaucoma, either as a standalone procedure or in combination with cataract surgery, with few complications.