Clinical Studies

Caution: investigational device not available for use or sale in the United States.

Clinical Trials

MINIject

MINIject is being studied in over 100 patients in clinical trials.

 

STAR-I

STAR-I 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. Further information can be found at https://clinicaltrials.gov/ct2/show/NCT03193736.

Results showed:

  • The primary endpoint was met with an average 39% IOP reduction to a mean of 14.2 mmHg at six months, using a mean of 0.3 IOP-lowering medications.
  • At two years, mean IOP was 13.8mmHg (-41%) with 48% of patients still able to discontinue topical medication usage, remaining medication-free at 24 months.
  • There were no serious adverse events related to the device or the procedure, and no patient required additional glaucoma surgery.
  • Minimal reduction in ECD was observed.

STAR-II

Similarly, in the STAR-II prospective trial, a total of 29 patients have been implanted with MINIject in eight European centres in France, Germany and Spain, and will be followed-up for two years. Further information can be found at https://clinicaltrials.gov/ct2/show/NCT03624361.

Results at 6 months showed:

  • The primary endpoint was met by far exceeding the pre-defined success rate (60%) at six months: > 75% of patients achieved diurnal IOP between 5 – 21mmHg with >20% IOP reduction from baseline.
  • Mean IOP reduction was 40%, with 55% of patients on no medication at six months.
  • A mean reduction of nearly two (1.8) IOP-lowering medications was achieved.

Please contact us for further information on the iSTAR Medical upcoming clinical program.

STARflo

Two multi-centre clinical studies were performed with the STARflo device.

 

The STARfloTM European Safety and Efficacy Study was a post-market, prospective, multi-centre clinical trial of the STARflo Glaucoma implant in 50 patients in Europe. The primary endpoint was the reduction in mean diurnal IOP at month 12 vs baseline. Secondary endpoints included safety and the reduction of IOP-lowering medication. Final results will be published in 2021. Further information can be found at https://clinicaltrials.gov/ct2/show/NCT02272569.

The STAR-LIFE study aims to document the benefit to patients following 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. Further information can be found at https://clinicaltrials.gov/ct2/show/NCT02825264.