A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)

Julián García Feijoó, Philippe Denis, Christoph Hirneiß, Florent Aptel, Lucía Perucho González, Zubair Hussain, Katrin Lorenz, Norbert Pfeiffer, STAR-II Investigators, Julián García Feijoó, Philippe Denis, Christoph Hirneiß, Florent Aptel, Lucía Perucho González, Zubair Hussain, Katrin Lorenz, Norbert Pfeiffer, STAR-II Investigators

Abstract

Precis: In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma.

Purpose: This study evaluates the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627) for surgical treatment of primary open-angle glaucoma in patients refractory to topical hypotensive medications.

Methods: In a prospective, interventional, single-arm, multicenter, European study (STAR-II), MINIject was successfully implanted in a stand-alone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal IOP ≤21 and >5 mm Hg with ≥20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361.

Results: At the 6-month follow-up, the primary endpoint was fulfilled, with 75.9% of patients reaching prospectively defined success. The mean IOP was reduced by 40.2% (9.9 mm Hg) to 14.7±6.0 mm Hg at 6 months from 24.6±3.8 mm Hg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% from 2.9±1.2 at baseline to 1.0±1.3. Furthermore, 79.3% of the patients had mean IOP ≤18 mm Hg, 82.8% achieved a ≥20% IOP reduction, and 55.2% were medication free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion, and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density.

Conclusion: Ab-interno supraciliary surgical implantation using MINIject DO627 in a stand-alone procedure significantly lowers IOP by 40% at the 6-month follow-up, while reducing the need for IOP-lowering medication.

Conflict of interest statement

Disclosure: J.G.F.: Santen, Alcon, Glaukos, iSTAR Medical, Thea, AJL. P.D.: Santen, Alcon, Glaukos, iSTAR Medical, Thea, Bausch & Lomb, Allergan. C.H.: SANTEN, iSTAR Medical. F.A.: Alcon, Allergan, Eyetechcare, Glaukos, iSTAR Medical, Santen, Thea. Z.H.: Vice President of Clinical and Regulatory Affairs, at iSTAR Medical. K.L.: Allergan, Ivantis Inc., MicroOptx, Implandata, Sensimed, Thea, Santen, Pfizer. N.P.: Allergan, Ivantis Inc., MicroOptx, Implandata, Sensimed, Thea, Santen, Pfizer. The remaining authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
MINIject implant and STAR material. © iSTAR Medical, Source: https://www.istarmed.com/products/miniject-migs/.
FIGURE 2
FIGURE 2
Mean intraocular pressure (IOP) over various timepoints up to the 6-month follow-up in the intention-to-treat population (n=29). Error bars are 95% confidence intervals.
FIGURE 3
FIGURE 3
Ultrasound biomicroscopy pictures of the MINIject implant in situ at 1 week postsurgery (A) and at 6 months (B).

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Source: PubMed

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