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Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial
  1. Philippe Denis1,
  2. Christoph Hirneiß2,
  3. Georges M Durr3,
  4. Kasu Prasad Reddy4,
  5. Anita Kamarthy4,
  6. Ernesto Calvo5,
  7. Zubair Hussain6,
  8. Iqbal K Ahmed7
  1. 1Hôpital de la Croix-Rousse, Lyon, France
  2. 2Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany
  3. 3Centre Hospitalier Universitaire de Montréal (CHUM), Montreal, Canada
  4. 4Maxivision Super Speciality Eye Hospital, Hyderabad, India
  5. 5Panama Eye Center (previously Clínica de Ojos Orillac-Calvo), Panama City, Panama
  6. 6iSTAR Medical, Wavre, Belgium
  7. 7Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada
  1. Correspondence to Georges M Durr, Department of Ophthalmology, Centre Hospitalier Universitaire De Montréal (CHUM), 1051 Rue Sanguinet, Montreal, Quebec H2X 3E4, Canada; georgesdurr{at}gmail.com

Abstract

Background/Aims The 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.

Methods This 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.

Results Mean 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/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD.

Conclusion This 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.

  • Glaucoma
  • Intraocular pressure
  • Treatment surgery
  • Aqueous humour
  • Anterior chamber
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Footnotes

  • Funding iSTAR Medical (Wavre, Belgium) has directly sponsored the STAR-I study. The sponsor participated in the design of the study, conducting the study and review of the manuscript. There is no grant number.

  • Competing interests PD: iSTAR Medical, Alcon, Allergan, Glaukos, Santen, Thea; CH: iSTAR Medical, Thea Pharma; GMD: Alcon, Allergan, Bausch & Lomb, Glaukos, Labtician, Novartis, MST, Santen, Sight Sciences; KPR, AK, EC: no financial interests; ZH: Vice President of Regulatory and Clinical at iSTAR Medical; IKA: Aequus, Aerie Pharmaceuticals, Alcon, Allergan, ArcScan, Bausch & Lomb, Beaver Visitec, Camras Vision, Carl Zeiss Meditec, CorNeat Vision, Ellex, ElutiMed, Equinox, Genentech, Glaukos, Gore, Iantech, InjectSense, Iridex, iSTAR Medical, Ivantis, Johnson & Johnson Vision, KeLoTec, LayerBio, Leica Microsystems, MicroOptx, New World Medical, Omega Ophthalmics, PolyActiva, Sanoculis, Santen, Science Based Health, Sight Sciences, Stroma, TrueVision, Vizzari.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. Data may be obtained from a third party and are not publicly available.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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