Trial reportThe British journal of ophthalmology2022
Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial.
Trial report in The British journal of ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03193736 (A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications), which is not on this map. Cited by 29 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, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Who cites it
29 citing papers in PubMed, 54 citations in OpenAlex.
- Efficacy and safety of a novel ab interno supraciliary HA-Mg biodegradable glaucoma drainage plate implantation in rabbit eyes.Journal of materials science. Materials in medicine · 2026Article
- A Systematic and Narrative Review of Safety and Complications in Minimally Invasive Glaucoma Surgery (MIGS) Between 2014-2024.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- Bibliometric and visualized analysis of the therapeutic application of suprachoroidal space from 2000 to 2024.International journal of surgery (London, England) · 2026Article
- 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 antifibrotic and vasoconstrictor effects of adrenaline in Schlemm's canal and suprachoroidal minimally invasive glaucoma surgery in primary open-angle glaucoma.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Article
- Meta-Analysis of MINIject vs. Two iStents as Standalone Treatment for Glaucoma with 24 Months of Follow-Up.Journal of clinical medicine · 2024Review
- IOP Reduction in Nonhuman Primates by Microneedle Injection of Drug-Free Hydrogel to Expand the Suprachoroidal Space.Translational vision science & technology · 2024Article
- Intraocular pressure control efficacy and safety of HA-Mg glaucoma drainage plate implantation in the anterior chamber of rabbit eyes.Journal of materials science. Materials in medicine · 2024Article
- Clinical Results of the MINIject Implant for Suprachoroidal Drainage.Journal of clinical medicine · 2024Article
- Five-year outcomes of ab interno Xen 45 gel stent implantation.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024Article
- Bio-Interventional Cyclodialysis and Allograft Scleral Reinforcement for Uveoscleral Outflow Enhancement in Open-Angle Glaucoma Patients: One-Year Clinical Outcomes.Clinical ophthalmology (Auckland, N.Z.) · 2024Article
- The Evolving Surgical Paradigm of Scleral Allograft Bio-Tissue Use in Ophthalmic Surgery: Techniques and Clinical Indications for Ab-Externo and Ab-Interno Scleral Reinforcement.Clinical ophthalmology (Auckland, N.Z.) · 2024Review
- New Devices in Glaucoma.Ophthalmology and therapy · 2023Review
- Recent Advancements in Glaucoma Surgery-A Review.Bioengineering (Basel, Switzerland) · 2023Review
- Clinical and Optical Coherence Tomography Evidence of Aqueous Humor Flow from the Suprachoroidal Space to Conjunctival Lymphatics.Vision (Basel, Switzerland) · 2023Article
- 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
- The PreserFlo MicroShunt in the Context of Minimally Invasive Glaucoma Surgery: A Narrative Review.International journal of environmental research and public health · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsThe current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma.
methodsThis prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication.
resultsMean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (-40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm
conclusionThis first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events. TRIAL REGISTRATION NUMBER: NCT03193736.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.