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

Abstract

ABSTRACT.Purpose: To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open-angle glaucoma na€ ıve of previous filtering surgery. Methods: Prospective non-comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open-angle glaucoma, intra-ocular 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 qualified surgical success (defined as IOP reduction from baseline ≥20% and IOP > 5 mmHg with possible re-intervention and without hypotensive medication adjunction) and complete surgical success (defined as IOP reduction from baseline ≥20%, IOP > 5 mmHg and IOP < 21 mmHg with possible re-intervention 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 with baseline, medication use, complications and re-interventions. Results: Intra-ocular pressure was significantly reduced (p < 0.05) from a mean pre-operative value of 28.2 AE 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 AE 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Qualified success was achieved in 63% of eyes (19/30) (mean IOP reduction of 37% in these eyes) and complete success in 46.7% of eyes (14/30) (mean IOP reduction of 37% in these eyes) at the last follow-up. No major intra-or post-operative complications occurred. Conclusions: The UC 3 procedure seems to be an effective and well-tolerated method to reduce IOP in patients with open-angle glaucoma without previous filtering surgery.

Ultrasound Cyclo-Plasty in Patients with Glaucoma: 1-Year Results from a Multicentre Prospective Study

“…A hypothetical model could be proposed to explain the causes of the failures according to the timeframe of their onset: early failures may reflect an insufficient amount of ciliary body tissue coagulated during the procedure [19], while late failures may reflect the possible re-epithelialization of the ciliary processes with the progressive recovery of their function [21,22], or the gradual narrowing of the stimulated uveoscleral outflow pathway [7,9,15].…”

“…Other additional limitations include the inhomogeneous patient characteristics which reflect a realworld glaucoma population, and the use of success criteria different from the World Glaucoma Association criteria [23] in order to conduct a more reliable comparison with the existing literature [18][19][20].…”

High-Intensity Focused Ultrasound Circular Cyclocoagulation in Glaucoma: A Step Forward for Cyclodestruction?

“…In these studies, preoperative IOP ranged from 27.5 to 39.1 mmHg, whereas postoperative IOP ranged from 17.1 to 23 mmHg at the last follow-up [16–18, 21, 88, 89]. …”

“…The mean number of the UC 3 procedure in the first 12 months ranged from 1.05 to 1.13 in the study of Aptel et al, while Denis et al reported percentages of retreatment from 17.6 to 29.4% in the 6- and 4-second dose regimens, respectively [17, 89]. Finally, all these studies did not report a significant reduction of the mean number of medications after the procedure, especially in the long-term studies.…”

“…Given the high rate of safety demonstrated in refractory glaucoma [16–21, 88], Aptel et al recently conducted a study to evaluate the efficacy and safety of UC 3 in patients with early glaucoma, naïve of any previous filtering surgery [89]. The authors reported a complete and qualified success of 46.7% and 63%, respectively, with a mean IOP reduction of 37% at 12 months, using the 6-second regimen.…”