Five-Year Safety And Efficacy Results Of A Supraciliary Drainage Device In Open Angle Glaucoma Patients (Star-Global)
Published 2026 - 44th Congress of the ESCRS
Reference: FP04.15 | Type: Free paper | DOI: 10.82333/2vhv-2s72
Authors: Prof. Antonio Maria Fea* 1 , A/Prof. Philippe Denis 2 , A/Prof. Christoph Hirneiss 3 , A/Prof. Iqbal Ike Ahmed 4
1Dipartimento di Scienze Chirurgiche,Clinica Oculistica,Torino,Italy, 2Ophthalmology,Hopital de la Crox Rousse,Lyon,France, 3Ophthalmology,LMU,Munich,Germany, 4University of Utah,John Moran Center,Salt Lake City,United States
Purpose
Purpose: The five-year safety and efficacy of a minimally invasive glaucoma surgery (MIGS) device, MINIject® (iSTAR Medical, Belgium), is described. The device was implanted ab interno into the supraciliary space in subjects with medically uncontrolled primary open-angle glaucoma.
Setting
Setting: The device was implanted in a standalone procedure in phakic and pseudophakic eyes in three prospective trials (STAR-I,II,III). The trials were completed in 66 subjects in 11 sites in Europe, Asia and Central America with two-year follow-up. Upon prior study completion, subjects were invited to enrol into the STAR-GLOBAL study
Methods
Methods: Patients were followed up annually until five years post implantation. Outcome measures were intraocular pressure (IOP), IOP-lowering medications (meds), and adverse events. Fifty-five subjects from the STAR-I,II,III trials were enrolled in the STAR-GLOBAL trial, with 47 completing 5-year post-implantation follow-up (85.4%). In this STAR-GLOBAL population, mean baseline diurnal IOP was 23.8±3.5 mmHg with a mean of 2.3±1.1 IOP-lowering meds (n=55). Patients were 49% female with mean age 69.3±9.7 years, and 51% of patients were phakic. The average visual field mean deviation was -6.5±6.0 dB at baseline (moderate severity) with 85% of patients having mild or moderate glaucoma severity.
Results
Results: At 2-years post-implantation, mean diurnal IOP was 14.1±4.0mmHg (-9.7mmHg, -40.0%; p<0.0001) on 1.4±1.3 meds (n=54). At 5-year (n=47), mean diurnal IOP was 14.8±5.6mmHg (-9.1mmHg, -38.4%; p<0.0001) on 1.5±1.4 meds (p<0.0001). Further, 83.0% of subjects achieved a >=20% IOP reduction, 78.7% and 55.3% achieved IOP <=18 mmHg and <=15 mmHg respectively, and 85.1% used the same or fewer medications at 5 years compared with baseline. Patients had similar IOP outcomes regardless of baseline glaucoma severity of mild, moderate or severe, or lens status. Since STAR-GLOBAL enrolment, adverse events related to MINIject included one IOP increase, one cataract progression and one non-clinically significant iris neovascularization.
Conclusions