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Review Glaucoma Clinical Research of Ultrasound Ciliary Plasty and Implications for Clinical Practice Philippe Denis Hospital Consultant and Head Ophthalmology Department, Croix-Rousse University Hospital, Lyon, France U ltrasound ciliary plasty (UCP) is a novel, non-invasive procedure for the control of intraocular pressure (IOP) in patients with open- angle glaucoma (OAG), and is particularly useful for refractory glaucoma after failed filtering surgery and patients with elevated risk of surgical failure due to high risk of conjunctival bleb scarring. A meta-analysis was performed of seven clinical trials, involving 251 patients, which evaluated the efficacy and safety of the procedure. The procedure was effective in reducing mean IOP across all indications and IOP reductions were similar in patients with refractory and non-refractory glaucoma. Safety and tolerability were good, with conjunctival hyperaemia being the most common side effect. Serious complications were rare. Procedures using the second-generation therapy probe were associated with superior reproducibility of IOP reduction compared with the first-generation probe. In summary, the procedure is a promising and effective treatment option for patients with refractory and non-refractory OAG. Keywords High-intensity focused ultrasound (HIFU), intraocular pressure (IOP), open-angle glaucoma (OAG), primary open-angle glaucoma (POAG), ciliary body, ultrasound ciliary plasty (UCP) Disclosure: Philippe Denis has been a consultant to Alcon, Alimera, Allergan, Eye Tech Care, Istar and Théa, received travel support from Alcon, Alimera, Allergan, Eye Tech Care, Istar, MSD, Pfizer and Théa, and been a lecturer for Alcon, Alimera, Allergan, Eye Tech Care, Istar, MSD, Pfizer, Théa and Zeiss. Acknowledgements: Medical writing assistance was provided by Catherine Amey at Touch Medical Media, UK, funded by Eye Tech Care. Compliance with Ethics Guidelines: This meta- analysis involves a review of the literature and did not involve any studies with human or animal subjects performed by the author. Authorship: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 10 October 2016 Accepted: 2 November 2016 Citation: European Ophthalmic Review, 2016;10(2):108–12 Corresponding Author: Philippe Denis, Service d’Ophtalmologie - Bâtiment R, Hôpital de la Croix-Rousse 103, Grande Rue de la Croix-Rousse, 69317 LYON cédex 04, France. E: philippe.denis@chu-lyon.fr Support: The publication of this article was supported by Eye Tech Care. The views and opinions expressed are those of the authors and do not necessarily reflect those of Eye Tech Care. The authors provided Eye Tech Care with the opportunity to review the article for scientific accuracy before submission. Any resulting changes were made at the author’s discretion. Interest in the application of ultrasound as treatment for glaucoma began in the 1980s. Following recent breakthroughs in the field of high-intensity focused ultrasound (HIFU) technology, a new procedure, known as ultrasound ciliary plasty (UCP) has been developed for selective, precise and gentle structural modification of the ciliary body, with sparing of the adjacent ocular structures. 1–3 The procedure uses a sterile, single-use therapy probe and a positioning cone, and is performed as follows: with the patient lying in the supine position, a polymer coupling cone is positioned on the eye globe, achieving good placement of the six active piezoelectric elements (ultrasound transducers) with respect to distance and centration (see Figure 1). Contact with the eye is maintained through a low-level vacuum (225 mmHg), which is applied by means of a suction ring at the cone base. A ring-shaped treatment probe (30 mm in diameter and 15 mm in height), which contains six transducers, is inserted in the upperportion of the coupling cone. Three probe models with different diameters are available to account for differences in ocular anatomy. The probe size is determined for each patient, either by ultrasound bio-microscopy (UBM) imaging or optical coherence tomography (OCT) of the anterior segment or by biometry performed at baseline. 3 The 4 ml cavity that is created between the eye, cone and treatment probe is filled with sterile, saline solution at room temperature (BSS, Alcon Inc., Fort Worth, TX, US, or equivalent product). The six elliptical cylinder-shaped impacts are centred on an 11–13 mm diameter circle, depending on the ring diameter chosen, and spread over the eye circumference, while avoiding the nasal–temporal meridian. A second-generation probe has now been developed and differs from the original version in its broader active transducer area (4 mm instead of 2.5 mm) and more precise temperature calibration of each single transducer. Other enhancements of the second-generation probe include: optimised suction and centring on the eye globe; improved coupling of ultrasound due to removal of air bubbles in the liquid which could disturb the ultrasound beam; optimised ergonomics and improved clip to attach the probe into the cone. Several prospective clinical studies on UCP treatment have been performed with a follow-up of up to 12 months (see Table 1). These studies have all supported the effectiveness of the procedure in reducing intra-ocular pressure (IOP) in patients with glaucoma. 4–9 This article describes a meta- analysis of the clinical trial data to date, with a focus on the second-generation probe compared with the previous one. In addition, patient outcome is compared for refractory patients after failed filtering surgery versus surgery naïve patients. Methods Data were pooled from seven clinical trials evaluating the first- or second-generation probe (five and two trials, respectively). Criteria for selection included refractory or non-refractory glaucoma patients with IOP >21 mmHg. Refractory means that the patient had at least one failed attempt at filtering surgery. As per the study protocols, glaucoma medications were kept constant for at least 2 months after the procedure and could then be adjusted at the physician’s discretion to 108 TOU C H ME D ICA L ME D IA