title: Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open-angle glaucoma naïve of previous filtering surgery.
  
  
  METHODS
  Prospective non-comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open-angle glaucoma, intra-ocular pressure (IOP) > 21 mmHg and with no previous filtering glaucoma surgeries were sonicated with a probe comprising six piezoelectric transducers. The six transducers were activated with a 6-s exposure time. Complete ophthalmic examinations were performed before the procedure and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after the procedure. Primary outcomes were qualified surgical success (defined as IOP reduction from baseline ≥20% and IOP > 5 mmHg with possible re-intervention and without hypotensive medication adjunction) and complete surgical success (defined as IOP reduction from baseline ≥20%, IOP > 5 mmHg and IOP < 21 mmHg with possible re-intervention and without hypotensive medication adjunction) at the last follow-up visit and vision-threatening complications. Secondary outcomes were mean IOP at each follow-up visit compared with baseline, medication use, complications and re-interventions.
  
  
  RESULTS
  Intra-ocular pressure was significantly reduced (p < 0.05) from a mean pre-operative value of 28.2 ± 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 ± 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Qualified success was achieved in 63% of eyes (19/30) (mean IOP reduction of 37% in these eyes) and complete success in 46.7% of eyes (14/30) (mean IOP reduction of 37% in these eyes) at the last follow-up. No major intra- or post-operative complications occurred.
  
  
  CONCLUSIONS
  The UC(3) procedure seems to be an effective and well-tolerated method to reduce IOP in patients with open-angle glaucoma without previous filtering surgery.
authors.affiliation: Department of Ophthalmology, University Hospital, CHU Grenoble, Joseph Fourier University, Grenoble, France.
authors.forename: Florent
authors.initials: F
authors.lastname: Aptel
authors.affiliation: Department of Ophthalmology, University Hospital, Lyon, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Denis
authors.affiliation: Department of Ophthalmology, Claude Huriez Hospital, CHRU de Lille, Lille, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Rouland
authors.affiliation: Department of Ophthalmology, Val de Grace Military Hospital, Paris, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Renard
authors.affiliation: Department of Ophthalmology, University Hospital, CHU Dijon, Dijon, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Bron
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002924:Ciliary Body / Q000601:surgery*; D005260:Female; D018463:Filtering Surgery; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000601:surgery*; D057086:High-Intensity Focused Ultrasound Ablation / Q000379:methods*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D014065:Tonometry, Ocular; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents
keywords: ciliary body; cyclocoagulation; glaucoma; ultrasound