title: Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of high-intensity focused ultrasound (HIFU) cyclocoagulation in reducing intraocular pressure (IOP) in patients with refractory glaucoma by using a novel miniaturized delivery device (EyeOP1).
  
  
  METHODS
  We conducted a 12-month open-label multicenter prospective study (EyeMUST1 Study). Patients with primary (primary open-angle glaucoma [POAG]) or secondary refractory glaucoma were treated in two groups depending on the duration of each ultrasound shot (group 1: 4 seconds; group 2: 6 seconds). The primary efficacy outcome was based on IOP reduction at 6 and 12 months.
  
  
  RESULTS
  Fifty-two patients were enrolled: 36 (69%) had POAG and 16 (31%) had secondary glaucoma. Group 1 (n = 24) and group 2 (n = 28) had similar demographics and baseline characteristics. In group 1, IOP was reduced from a mean preoperative value of 29.7 ± 7.7 mm Hg (n = 3.5 glaucoma medications) to a mean postoperative value of 21.3 ± 6.7 mm Hg (n = 3.5 glaucoma medications) and 20.1 ± 6.7 mm Hg (n = 3.2 glaucoma medications) at 6 and 12 months, respectively. In group 2, IOP was reduced from a mean preoperative value of 29.0 ± 7.4 mm Hg (n = 3.3 glaucoma medications) to a mean postoperative value of 20.2 ± 7.4 mm Hg (n = 3.4 glaucoma medications) and 18.5 ± 6.6 mm Hg (n = 3.5 glaucoma medications) at 6 and 12 months, respectively. At 12 months, the IOP reduction was sustained in both groups (32% IOP reduction in group 1 and 36% IOP reduction in group 2). The overall tolerance of the technique was good, with no serious adverse events.
  
  
  CONCLUSIONS
  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.).
authors.affiliation: Hôpital de la Croix-Rousse, Service d'Ophtalmologie, Hospices Civils de Lyon, Lyon, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Denis
authors.affiliation: Service d'Ophtalmologie, Centre Hospitalier Universitaire de Grenoble, Grenoble, France.
authors.forename: Florent
authors.initials: F
authors.lastname: Aptel
authors.affiliation: Service d'Ophtalmologie, Hôpital Claude Huriez, CHRU de Lille, Lille, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Rouland
authors.affiliation: Service d'Ophtalmologie 3, Centre Hospitalier National des Quinze-Vingts, Paris, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Nordmann
authors.affiliation: Institut du Glaucome, Fondation Hôpital Saint-Joseph, Paris, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Lachkar
authors.affiliation: Service d'Ophtalmologie, Hôpital d'Instruction des Armées du Val de Grâce, Paris, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Renard
authors.affiliation: Centre Ophtalmologique Kléber, Lyon, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Sellem
authors.affiliation: Service d'Ophtalmologie 2, Centre Hospitalier National des Quinze-Vingts, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Baudouin
authors.affiliation: Service d'Ophtalmologie, Hôpital Général, Dijon, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Bron
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002924:Ciliary Body / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000601:surgery*; D057086:High-Intensity Focused Ultrasound Ablation / Q000379:methods*; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D013508:Ophthalmologic Surgical Procedures / Q000379:methods*; D011446:Prospective Studies; D013997:Time Factors; D014065:Tonometry, Ocular; D016896:Treatment Outcome
keywords: ciliary body; methods, treatment outcome; therapy, intraocular pressure, miniaturization; ultrasonography, glaucoma