ESCRS - PP09.01 - Five-Year Safety And Efficacy Results Of A Supraciliary Drainage Device In Open Angle Glaucoma Patients (Star-Global)

Five-Year Safety And Efficacy Results Of A Supraciliary Drainage Device In Open Angle Glaucoma Patients (Star-Global)

Published 2024 - 42nd Congress of the ESCRS

Reference: PP09.01 | Type: Free paper | DOI: 10.82333/0fyd-4k65

Authors: Henny Beckers* 1 , Philippe Denis 2 , Christoph Hirneiss 3 , Iqbal Ike Ahmed 4

1University Eye Clinic,Maastricht UMC+,Maastricht ,Netherlands, 2Ophthalmology,Croix-Rousse University,Lyon,France, 3Ophthalmology,Klinikum der Universitat Munchen,Munchen,Germany, 4John Moran Eye Center,University of Utah,Utah,United States

Purpose

 

To describe the 5-year safety and efficacy of a novel, minimally-invasive glaucoma surgery (MIGS) device (MINIject®; iSTAR Medical, Belgium) implanted ab interno into the supraciliary space in patients with medically-uncontrolled open-angle glaucoma (OAG).

Setting

In the STAR-I prospective, multi-centre, non-randomised, interventional trial, the implant was inserted into the supraciliary space in a standalone procedure in phakic and pseudophakic eyes with no medication washout. The trial was completed 2 years post-implantation by 21 patients in 2 sites in Asia and Central America.

Methods

Upon STAR-I study completion, patients were invited to enrol in the STAR-GLOBAL study to continue follow-up annually from 3 until 5 years. Intraocular pressure (IOP) and IOP-lowering medication use were recorded annually, as well as a safety evaluation including adverse events and measurements of corneal endothelial cell density (ECD). Results from 14 patients who completed 5-year follow-up (67% of patients who completed the STAR-I trial) are reported here.

Results

Patients implanted with MINIject in the STAR-I trial had a mean baseline diurnal IOP of 23.2±2.9 mmHg on 2.0±1.1 IOP-lowering medications (n=25). At 2-year follow-up (n=21), mean diurnal IOP was 13.8±3.5mmHg (-9.6mmHg, -40.7%; p<0.0001) on 1.0±1.3 medication. At 5-year follow-up (n=14) in the STAR-GLOBAL trial, mean diurnal IOP was 17.2±5.0mmHg (-6.4mmHg, -27.6%; p<0.0001) on 1.7±1.5 medications. At 5 years, 69% of patients achieved an IOP reduction of >=20% from baseline, 69% achieved an IOP <=18 mmHg, and 21% of patients were medication-free. The only adverse event since STAR-GLOBAL study enrolment was 1 case of ECD loss requiring implant trimming. The mean reduction in central ECD since baseline was 10.4% at the 5-year follow-up.

Conclusions

In an ethnically diverse cohort of patients, meaningful efficacy up to 5-years post-implantation was achieved in the majority of patients. This supraciliary MIGS procedure offers a valuable bleb-free treatment option for patients with glaucoma requiring sustained, low target IOPs.