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Clinical Research of Ultrasound Ciliary
Plasty and Implications for Clinical Practice
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: firstname.lastname@example.org
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