Cyclocoagulation of the Ciliary Bodies by High-Intensity Focused Ultrasound: A 12-Month Multicenter Study

Abstract

The new miniaturized HIFU EyeOP1 delivery device seems to be effective in decreasing IOP in patients with refractory glaucoma. The technology offers a good safety profile. (ClinicalTrials.gov number, NCT01338467.).

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

“…However, these success criteria have been previously used in several previous glaucoma surgical trials, particularly in the three main clinical studies evaluating the new ultrasonic ciliary body coagulation device, therefore facilitating comparisons of treatments outcomes among studies (Shaarawy et al 2009;Aptel et al 2011Aptel et al , 2014aDenis et al 2015). We found a mean IOP reduction of 30% in all patients treated, with an IOP decrease more than 20% in 63% of the patients (mean IOP reduction of 37% in those patients).…”

“…In the first multicenter study conducted in 52 patients with primary and secondary open-angle glaucoma, a first group of patients was treated with a 4-s exposure duration for each shot and a second group of patients with a 6-s exposure duration (Denis et al 2015). Patients were followed for at least 1 year.…”

“…Some patients with an IOP response insufficient to reach the target intraocular pressure were retreated in both multicenter studies (Aptel et al 2014a;Denis et al 2015). The six transducers were activated, and the orientation of the device was unchanged (no rotation).…”

“…The first one was a pilot study mainly designed to evaluate the feasibility and safety of the new method in a small number of eyes with refractory and very advanced glaucoma ). The two other studies were multicenter studies designed to evaluate the efficacy and safety of the method in eyes with open-angle glaucoma and less advanced disease than those treated in the pilot study, but still refractory to conventional surgery (at least one previous failed filtering surgery) (Aptel et al 2014a;Denis et al 2015). As these three studies have demonstrated that the method is well tolerated, particularly with no IOP spikes or major IOP increases in the early follow-up and, over the long term, no cases of severe hypotony or phthisis, some of the most serious adverse effects of the currently available cyclodestructive methods, a subsequent study was designed and conducted to evaluate the efficacy and safety of ultrasonic circular cyclocoagulation in patients with early glaucoma na€ ıve of any previous filtering surgery.…”

Ultrasound Cycloplasty in Glaucoma – Mechanisms of Action and their Possible Impact on Intraocular Pressure

“…Unlike reduced aqueous production, an increase in the aqueous outflow via the uveoscleral pathway is perhaps a less expected mechanism of action of UCP that nonetheless has been hypothesised on multiple occasions. 11,12,[21][22][23] Aptel observed in 2014 that a fluid space could be seen between the sclera and the ciliary body, and between the sclera and the choroid adjacent to treated areas, 21,24 and hypothesised that this corresponds to an area where the opening of the space should lead to an increase of the aqueous outflow via the uveoscleral pathway. A more recent prospective, observational monocentric study from Rouland and Aptel, using three-dimensional ultrasound biomicroscopy (UBM) that included 24 eyes from 19 patients, demonstrated that, in addition to reduction in aqueous humour production, UCP treatment caused an increase in aqueous humour outflow due to uveoscleral pathway opening.…”