Ultrasonic circular cyclo coagulation in patients with primary open‐angle glaucoma: preliminary results of a multicenter clinical trial

Abstract

Purpose To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients with primary open‐angle glaucoma (POAG). Methods Prospective multicenter clinical trial. 39 eyes of 39 patients with POAG, intraocular pressure (IOP) > 21 mmHg, an average of 1.65 failed previous surgeries and an average of 3.2 hypotensive medications were insonified with a probe comprising 6 piezoelectric transducers. 18 patients (group 1) were treated with a 4 seconds exposure time for each shot and 21 patients (group 2) with a 6 seconds exposure time. Follow‐up visits were performed at 1 day, 1 week, 1, 2, 3, 6 and 12 months after. Results IOP was significantly reduced in both groups (p<0.05), from a mean preoperative value of 28.9 ± 6.8 mmHg in group 1 and 29.2 ± 6.9 mmHg in group 2 to a mean value of 18.1 ± 4.4 mmHg in group 1 and 16.1 ± 8,5 mmHg in group 2 at last follow‐up. Success (IOP reduction >20%) was achieved in 15 of 18 (83%) eyes of the group 1 with an average of IOP decrease of 42% and in 19 of 21 (90%) eyes of the group 2 with an average of IOP decrease of 49%. No major intra‐ or post‐operative complications occurred. Conclusion UC3 seems to be an effective and well‐tolerated method to reduce intraocular pressure in patients with POAG. Commercial interest

Treatment of refractory open-angle glaucoma using ultrasonic circular cyclocoagulation: a prospective case series

“…A second large multicenter study evaluating the longterm efficacy and safety of this procedure on a larger number of patients having less advanced open-angle glaucoma is currently in progress (clinicaltrial.gov registration #NCT01338467) 14 . As the tolerability and safety profile of this new method of cyclocoagulation is good, it also seems logical to compare it to filtering surgery as a second line treatment, after medical treatment.…”

Treatment of glaucoma with high intensity focused ultrasound

“…Taking advantage of recent advances in the field of HIFU, a miniaturised device allowing selective, reproducible and minimally invasive ciliary body coagulation was recently developed [51][52][53][54][55][56].…”

“…Visual acuity remained statistically unchanged. In the first multicentre study, no IOP spikes occurred just after the procedure or during follow-up [55]. Eight patients were retreated with HIFU (n ¼ 7) or diode laser (n ¼ 1) due to lack of efficacy.…”

“…Retreatment: Some patients having an IOP response insufficient to reach the target IOP were retreated in the two multicentre studies [55,56]. The six transducers were activated and the orientation of the device was unchanged (no rotation); however, the diameter of the probe used for the second treatment was different from that used for the first treatment, allowing treatment of a more anteriorly or posteriorly located part of the ciliary body.…”

“…In the first multicentre study conducted in 60 patients with primary and secondary open-angle glaucoma, a first group of patients were treated with a 4-s exposure for each shot and a second group of patients with a 6-s exposure [55]. Patients were followed for at least 1 year.…”