ESCRS - PP27.07 - Real-Life Safety And Efficacy Results Of A Supraciliary Drainage Device At 24 Months Post-Implantation (Star-Life)

Real-Life Safety And Efficacy Results Of A Supraciliary Drainage Device At 24 Months Post-Implantation (Star-Life)

Published 2026 - 44th Congress of the ESCRS

Reference: PP27.07 | Type: Free paper | DOI: 10.82333/nhg0-en54

Authors: Mr Vincent Dubois* 1 , Prof. Kin Sheng Lim 2 , Dr Ewald Lindner 3 , Prof. Dr Swaantje Grisanti 4 , Dr Karsten Klabe 5 , Prof. Dr Burkhard Dick 6 , A/Prof. Kaweh Mansouri 7

1University Hospitals of Liverpool Group,Liverpool,United Kingdom, 2St. Thomas' Hospital,London,United Kingdom, 3Medizinische Universitat,Graz,Austria, 4Universitätsklinikum Schleswig-Holstein,Lübeck,Germany, 5Breyer, Kaymak & Klabe Augenchirurgie,Düsseldorf,Germany, 6University Eye Hospital,Knappschaftskrankenhaus,Bochum,Germany, 7Eye Department,University of Colorado,Denver,United States;Glaucoma Research Center,Montchoisi Clinic,Lausanne,Switzerland

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 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. A preliminary, interim analysis of the first 140 patients with 24-month follow-up in 13 sites in the UK, Switzerland, Germany and Austria was performed. 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.

Methods

The primary endpoint was the reporting of unexpected incidents and/or serious reportable incidents. Secondary endpoints included intraocular pressure (IOP) measurements and ocular hypotensive medication ingredient (meds) use compared with baseline. Patients were 55% female with mean age of 72.6±9.7. There were 71.6% treated in a standalone procedure and 57% were pseudophakic. The majority of patients were diagnosed with primary open-angle glaucoma (73%) or pseudoexfoliative glaucoma (17%). 42% had prior surgery in the study eye (other than cataract surgery/ SLT). Mild-to-moderate glaucoma was reported in 66% patients and mean visual field mean deviation was -9.5±7.6dB. Carbonic anhydrase inhibitors were used by 49% patients at baseline.

Results

Mean pre-operative and 24-month IOPs were 21.3±7.3mmHg on 2.8±1.7 meds and 14.5±4.6mmHg (-6.2mmHg, -23.8%; p<0.0001) on 1.9±1.9 meds (-1.0; p<0.0001) respectively. Furthermore, 56.4% patients had >/=20% IOP reduction, 80.7% had IOP </=18mmHg, and 81.4% were on the same or fewer medications at 24 months. At 24 months, there was no difference in IOP and medication reduction after standalone vs combined-cataract surgery. There were no unexpected nor serious reportable incidents. Serious incidents (n>1) included: IOP increase (6.9%), hypotony (2.3%), device migration or mispositioning (2.3%) and hyphaema (1.4%).

Conclusions

In a real-life, diverse population in the STAR-LIFE study, a significant mean IOP reduction of 6.2mmHg was achieved 24 months after treatment with MINIject, in addition to a mean 1.0 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 low rates of serious incidents.