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.

High intensity focused ultrasound cyclocoagulation in dogs with primary glaucoma: a preliminary study

“…Transient benign conjunctival hyperaemia was observed in humans and was more frequent in patients with higher levels of energy delivered to the eye (Denis et al, 2015). Other post-operative complications reported in humans and not observed in dogs were punctate keratitis, corneal ulcer, blepharitis and discrete uveal effusions (Aptel et al, 2011(Aptel et al, , 2014b(Aptel et al, , 2016Denis et al, 2015). In human patients, a duration-effect was observed with the sonication procedure.…”

“…As the other patients did not exhibit signs of pain or hypertensive spikes, we hypothesized that pain was linked to the elevated IOP and not with the procedure itself. The cause of the rebound effect (RE) after sonication remains unknown and seems unusual in humans (Aptel et al, 2011(Aptel et al, , 2014b(Aptel et al, , 2016Denis et al, 2015). RE has been described in 92% of dogs after cyclophotocoagulation (Hardman and Stanley, 2001) whereas it was only observed in 10% of cases after cyclophotocoagulation associated with an Ahmed gonioimplantation (Sapienza and van der Woerdt, 2005).…”

“…The use of HIFU in the treatment of glaucoma in humans was first described in the eighties with promising results (Coleman et al, 1985a(Coleman et al, ,b, 1986Burgess et al, 1986). Temporarily abandoned because of the size of the device and the time required for the procedure, HIFU has recently sparked again the interest of ophthalmologists (Aptel et al, , 2014b(Aptel et al, , 2016Denis et al, 2015). Evolution of the technologies led to the manufacturing of smaller and more efficient devices, allowing safer and shorter procedures (Charrel et al, 2011).…”

A Comparative Study between Ultrasound Cycloplasty and Cyclocryotherapy for the Treatment of Neovascular Glaucoma

“…e device consists of a command module and a disposable therapy device including a positioning cone and a treatment probe. e treatment probe uses six transducers in a circle to locate the ciliary process with sub-millimeter accuracy and a strict temperature control [4,11]. e operator can determine the treatment dosage precisely according to the patients' condition.…”

“…In most patients with advanced NVG, hypotensive medication has been unable to control the IOP and surgery has become the only possible treatment option [4]. Many surgical methods can be used to reduce the IOP in NVG.…”