The MINIjectTM study is a prospective, open, multi-centre clinical trial analysing the efficacy and safety of the MINIject investigational device in 25 patients with open angle glaucoma uncontrolled by topical hypotensive medications. MINIject is intended to be used to reduce intraocular pressure (IOP) by channelling aqueous humor out of the anterior chamber to a sub-scleral location, thus enhancing the physiological uveoscleral outflow. The primary study objective is to assess the efficacy of the implant, in terms of IOP reduction. The primary endpoint is the absolute reduction in mean diurnal IOP compared to baseline at 6-month follow-up. Secondary endpoints include IOP reduction at 12 and 24-month follow-up, and the reduction in the number of topical hypotensive medications at 6, 12 and 24-months compared to baseline. This trial has been registered on ClinicalTrials.gov (NCT03193736). Further information can be found at https://clinicaltrials.gov/ct2/show/NCT03193736.
Primary endpoint results showed that the implantation of MINIject resulted in an average 39% IOP reduction to a mean of 14.2 mmHg at six months. In addition, 87.5% of patients were able to discontinue topical medication usage and remained medication-free at six months. There were no serious ocular adverse events.
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There are 2 on-going trials studying the STARflo device.
The STARfloTM European Safety and Efficacy Study is a post-market, prospective, multi-centre clinical trial of the STARflo Glaucoma implant in approximately 50 patients in Europe. The objective of this study is to assess the effectiveness of the STARflo Glaucoma Implant for patients with open angle glaucoma, in terms of IOP reduction. Secondary objectives include safety and the reduction of IOP-lowering medication use. The primary endpoint is the reduction in mean diurnal intraocular pressure at month 12 vs baseline (mmHg). Final results are expected in 2018. This trial has been registered on ClinicalTrials.gov (NCT02272569). Further information can be found at https://clinicaltrials.gov/ct2/show/NCT02272569.
The STAR-LIFE study is a registry with the aim of documenting the benefit to patients following the implantation of the STARflo implant in a “real-world” patient population, and to learn about surgical practices. The objective is to document the implant’s effectiveness in terms of IOP reduction in open angle glaucoma patients and the reduction in the number of concomitant IOP-lowering medications. The study is designed to allow collection of patient data either retrospectively or prospectively for up to 5 years post-implantation in up to 150 patients. This trial has been registered on ClinicalTrials.gov (NCT02825264). Further information can be found at https://clinicaltrials.gov/ct2/show/NCT02825264.