1. Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial
- Author
-
Georges M. Durr, Kasu Prasad Reddy, Iqbal K. Ahmed, Philippe Denis, Anita Kamarthy, Zubair Hussain, Ernesto Calvo, and Christoph Hirneiß
- Subjects
030213 general clinical medicine ,Intraocular pressure ,medicine.medical_specialty ,genetic structures ,medicine.medical_treatment ,Glaucoma ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,Tonometry, Ocular ,0302 clinical medicine ,medicine ,Glaucoma surgery ,Humans ,In patient ,Prospective Studies ,Adverse effect ,Glaucoma Drainage Implants ,Anterior chamber ,Glaucoma medication ,business.industry ,Aqueous humour ,First in human ,Clinical Science ,medicine.disease ,Sensory Systems ,eye diseases ,Surgery ,Endothelial cell density ,Ophthalmology ,Treatment Outcome ,030221 ophthalmology & optometry ,sense organs ,business ,Treatment surgery ,Glaucoma, Open-Angle ,Follow-Up Studies - 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/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.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 numberNCT03193736.
- Published
- 2020