STARfloTM, a new suprachoroidal drainage implant for glaucoma: 3 months clinical results

Purpose STARfloTM is a silicone implant for IOP reduction in POAG. STARfloTM is made with STAR® Biomaterial, a flexible tissue‐friendly, micro‐porous structure designed to reduce fibrotic response and maximize long‐term performance. The safety and performance endpoints of the study were; 1. Feasibility of STARfloTM device implantation; 2. Incidence of device and procedure related‐complication and unanticipated adverse device effects; 3. Reduction in IOP; 4. Reduction in number of glaucoma medications. Methods 4 patients with advanced POAG and preop IOP>21 mmHg underwent STARfloTM implantation in suprachoroidal space. Outcome measures were IOP, biomicroscopy, ophthalmoscopy and the number of anti‐glaucomatous drugs on D1, W1, M1 and M3 postop. Results Mean preop IOP was 37.0±8.4 mmHg and mean preop glaucoma medication was 2.5±1 intake/day. 1m postop (4 cases), mean IOP decreased to 21.8±9.7 mmHg (38.4% reduction/patient) and mean glaucoma medication decreased to 1.0±1.2 intake/day. At 3 m (3 cases), mean IOP was 25±11.3 mmHg (33.1% reduction/patient) and mean glaucoma medication was 1±1 intake/day. No adverse events were reported during or immediately postop and no device‐related serious adverse events were reported during follow‐up. Early complications were: transient hypotony for 2 cases, transient choroidal hemorrhage in 1 case, transient abnormal macula in 1 case. In 3 cases, bleb disappeared at month 1, and in 1 case it disappeared at month 3. 1 patient, with posttraumatic COAG, was dropped 4 m after implantation. Conclusion Early results for STARflo met the safety and performance endpoints of study. STARflo reduces IOP in refractory glaucoma, Commercial interest