Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial

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.

Biocompatibility Evolves: Phenomenology to Toxicology to Regeneration

“…[266,267] Precision porous polymers with pores in 30-40 µm range have been used for a number of years as glaucoma draining devices to reduce intraocular pressure. [268] A vascular prosthesis that heals without the fibrotic sheath that impedes graft mechanical compliance is now in clinical trials (Evaluation of STARgraft AV for Hemodialysis Access, Clinical-Trials.gov Identifier: NCT03916731). Implanted glucose sensors fail in providing accurate, long-term glucose measurements, probably due to fibrotic blockage of the sensing element.…”

Medical Applications of Porous Biomaterials: Features of Porosity and Tissue‐Specific Implications for Biocompatibility

“…Perhaps the most frequently employed porogen leaching method for researching the effect of porosity on biocompatibility is sphere templating (Figure 2A). [4,9,10,[38][39][40][41][42][43] Devices including hemodialysis grafts [44] and supraciliary drainage implants for glaucoma treatment [45,46] are fabricated using sphere templating, illustrating the translatability of this method. Sphere templating is a subtractive method which creates pores by first forming an array of sintered sphere microparticles, then filling the spaces of the array with polymer precursors, solidifying the polymer, and finally removing the beads so that just the polymer scaffold remains.…”

“…[ 45,46,48,289 ] In a recent clinical trial, the MINIject implant was found to effectively reduce intraocular pressure and reduce the need for medications across the two year study, without any serious adverse events. [ 46 ]…”

The surgical management of glaucoma: A review

“…The MINIject (iSTAR Medical) is an ab interno supraciliary device made of the STAR biocompatible material, which is a soft, microporous and flexible silicone. 218 It is 5 mm long and is oblong, 1.1 mm by 0.6 mm in cross-section, with a green ring at 0.5 mm for accurate AC positioning. The first human study showed a 40.7% reduction in IOP and a 47.6%/100% complete/ qualified success at 2 years with a 5% reduction in ECD.…”

“…The first human study showed a 40.7% reduction in IOP and a 47.6%/100% complete/ qualified success at 2 years with a 5% reduction in ECD. 218…”