Trial reportJournal of glaucoma2020
A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II).
Trial report in Journal of glaucoma, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03624361 (A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications), which is not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Who cites it
13 citing papers in PubMed.
- A Systematic and Narrative Review of Safety and Complications in Minimally Invasive Glaucoma Surgery (MIGS) Between 2014-2024.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- Real-World Data of the First UK Series of MINIject Supraciliary Glaucoma Implant with 6 Months Follow-Up.Ophthalmology and therapy · 2025Article
- Anterior-Segment Optical Coherence Tomography Imaging of Patients Undergoing Supraciliary Glaucoma Drainage Device Implantation.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Article
- Two-Year Data on the Efficacy and Safety of the MINIject Supraciliary Implant in Patients with Medically Uncontrolled Primary Open-Angle Glaucoma.Journal of clinical medicine · 2025Article
- Preliminary Short-Term Results of Supraciliary Ab-Interno MINIjectClinical ophthalmology (Auckland, N.Z.) · 2025Article
- Meta-Analysis of MINIject vs. Two iStents as Standalone Treatment for Glaucoma with 24 Months of Follow-Up.Journal of clinical medicine · 2024Review
- In vivo evaluation of a nanotechnology-based microshunt for filtering glaucoma surgery.Scientific reports · 2024Article
- Recent Advancements in Glaucoma Surgery-A Review.Bioengineering (Basel, Switzerland) · 2023Review
- Managing primary open-angle glaucoma in the setting of suboptimal surgical outcomes in the fellow eye.Journal of cataract and refractive surgery · 2023Article
- [Minimally invasive glaucoma surgery-Comparison of angle based procedures].Die Ophthalmologie · 2023Review
- Surgical Augmentation of the Suprachoroidal Space: A Novel Material and Implant.Clinical ophthalmology (Auckland, N.Z.) · 2023Review
- Can We Ever Win with a Suprachoroidal Implant?Journal of current glaucoma practiceArticle
- Real-world efficacy of the intrascleral ciliary sulcus suprachoroidal microtube technique in Black and Afro-Latinx patients with glaucoma: a 1-year retrospective study.Therapeutic advances in ophthalmologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
precisIn 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.
methodsIn 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.
resultsAt 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.
conclusionAb-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.
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