Multicenter clinical trial of high‐intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery

Abstract

PurposeTo evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open‐angle glaucoma naïve of previous filtering surgery.MethodsProspective non‐comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open‐angle glaucoma, intraocular pressure (IOP) > 21 mmHg and with no previous filtering glaucoma surgeries were sonicated with a probe comprising six piezoelectric transducers. The six transducers were activated with a 6‐s exposure time. Complete ophthalmic examinations were performed before the procedure and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after the procedure. Primary outcomes were surgical success (defined as IOP reduction from baseline ≥ 20% and IOP > 5 mmHg with possible retreatment and without hypotensive medication adjunction) at the last follow‐up visit and vision‐threatening complications. Secondary outcomes were mean IOP at each follow‐up visit compared to baseline, medication use, complications and retreatments.ResultsIOP was significantly reduced (p < 0.05) from a mean preoperative value of 28.2 ± 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 ± 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Success was achieved in 63% of eyes (19/30) at 12 months (mean IOP reduction of 37% in these eyes). No major intra‐ or postoperative complications occurred.ConclusionsThe ultrasonic circular cyclocoagulation procedure seems to be an effective and well‐tolerated method to reduce IOP in patients with open‐angle glaucoma without previous filtering surgery.