Final results of a supraciliary drainage device in patients with open angle glaucoma in a first-in-human study (STAR-I)
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First Author: A.Kamarthy INDIA
Co Author(s): K. Reddy P. Denis C. Hirneiß E. Calvo I. Ahmed
To describe the safety and efficacy profile of a novel, supraciliary, micro-invasive glaucoma surgery (MIGS) drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in eyes with medically-uncontrolled open-angle glaucoma. ClinicalTrials.gov: NCT03193736
A prospective, multicenter, interventional, single-arm trial (STAR-I).
Twenty-five eyes were successfully implanted with a 5mm long supraciliary device in a stand-alone, ab interno procedure. The device is made of biocompatible STAR material which is soft and flexible silicone in a micro-porous network design. Intraocular pressure (IOP), medication use, and other ocular parameters were evaluated preoperatively and postoperatively through 24 months, at pre-specified timepoints. The primary endpoint of the study is IOP reduction at 6 months compared to baseline analyzed with a paired t-test. Safety evaluation included the nature and frequency of adverse events. The final study results at 24-months are reported here.
Baseline diurnal IOP was 23.1(0.6)mmHg (mean±standard error[SE]) using 2.0±1.1 IOP-lowering medication ingredients (mean±standard deviation[SD]). At the 6-month primary endpoint follow-up, mean diurnal IOP was reduced by 9.0mmHg or 39% from baseline, and the number of medication ingredients was 0.3±0.7. At 24-month follow-up, mean(SE) diurnal IOP was 13.8(0.8), a mean reduction of 9.55mmHg or 41% from baseline, and the number of IOP-lowering medications was 1.0±1.3. Furthermore, 10/21 (48%) patients were medication-free, 20/21 (95.2%) achieved an IOP ≤18mmHg, and all patients achieved an IOP reduction of ≥20% from baseline. No serious ocular adverse events or additional glaucoma surgery were reported.
This supraciliary MIGS device implanted in a standalone procedure was shown to be a powerful treatment option to significantly reduce IOP and substantially reduce the need for medication in patients with open-angle glaucoma up to 24 months post-implantation, without causing serious ocular adverse events and with no additional glaucoma surgeries required.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented