Clinical studies and publications

PROGRESSIVE AND COHERENT CLINICAL DEVELOPMENT

Initial investigations were carried out on patients with refractory glaucoma where all other existing medical and therapeutic options, including surgery, had failed. In consideration of the exceptional tolerance profile observed, the EyeMUST-3 study was conducted on patients who were naive of surgery. After 12 months of follow-up, results from this study performed on 30 patients demonstrate the efficacy and tolerance of the treatment on patients with uncontrolled glaucoma on hypotonic medication.

2013

EyeMUST-3

Multicenter prospective clinical study (5 centers). Population : primary open-angle glacoma, IOP>21mmHg, no history of filtering surgery.
PUBLICATION : " Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery."Aptel F, Denis P, Rouland JF, Renard JP, Bron A.
Acta Ophthalmol. 2015 Nov 7. doi: 10.1111/aos.12913.
Acta Ophthalmologica. IF = 2,84 http://www.ncbi.nlm.nih.gov/pubmed/26547890

POSTERS :
EVER 2014 Congress (T044) : “Multicenter Clinical Trial of Ultrasonic Circular CycloCoagulation in glaucoma patients without previous filtering surgery. Results at 12 months”.F. Aptel, P.Denis, JF.Rouland, JP.Renard, A.Bron
ClinicalTrials.gov Identifier: NCT01791673

2012

Post market study

Post market multicenter study. 28 patients -Population : primary open-angle glaucoma,  IOP>21mmHg, at least one failed filtering surgery.  
PUBLICATION :“Treatment of refractory open-angle glaucoma using ultrasonic circular cyclocoagulation: a prospective case series.”Aptel F1, Dupuy C, Rouland JF
Curr Med Res Opin. 2014 Aug;30(8):1599-605. doi: 10.1185/03007995.2014.910509. Epub 2014 Apr 16.

2012

EyeMUST-2

International multicenter prospective study - 100 patients (6 countries) -Population : refractory glaucoma, IOP>21mmHg, at least one failed filtering surgery: « High-intensity focused ultrasound(HIFU) treatment in refractory glaucoma patients. Results at 1 year of prospective clinical study”
PUBLICATION : " High-intensity focused ultrasound treatment in refractory glaucoma patients : results at 1 year of prospective clinical study".S.Melamed, M.Goldenfeld, D.Cotlear, A.Skaat, I.Moroz
Europ J of Ophthalmol. 2015 May13:0. doi: 10.5301/ejo5000620

European Journal of Ophthalmology. IF=1,058 http://www.ncbi.nlm.nih.gov/pubmed/25982212
ClinicalTrials.gov Identifier : NCT01592955

POSTERS:
ARVO 2015 Congress : “Safety and Efficacy of High-Intensity Focused Ultrasound Cyclocoagulation in Refractory Glaucoma." K.Mansouri, T.Shaarawy - University of Geneva, Switzerland. 
ARVO 2013 Congress (D0270): “Clinical efficacy of ultrasonic circular cyclo coagulation in refractory glaucoma. Preliminary results”.Paolo Fogagnolo, Maurizio Digiuni, EmanueleMaggiolo, Luca M. Rossetti

2011

EyeMUST-1

Multicenter prospective study - 60 patients (9 centers). – Population : refractory glaucoma, PIO>21mmHg, at least one filtering surgery failure. 
Evaluation of the safety of focused ultrasound treatment
PUBLICATION : « Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound : a 12-month multicenter study. Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. » Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.

IOVS jan15 – IF 3.66 http://www.ncbi.nlm.nih.gov/pubmed/25604688
ClinicalTrials.gov Identifier:NCT01338467

2010

Pilot study

Pilot multicenter prospective study - Population: End-stage glaucoma, IOP>21mmHg, reduced visual field and a history of multiple filtration surgery 
Evaluation of the safety of focused ultrasound treatment.
PUBLICATION : "Miniaturized high-intensity focused ultrasound device in patient with glaucoma: a clinical pilot study". Aptel F, Charrel T, Lafon C, Romano F, Chapelon JY, Blumen-Ohana E, Nordmann JP, Denis P Invest. Ophthalmol Vis Sci. 2011 Nov 11 ; 52(12) : 8747-53 doi :10.1167/iovs.11-8137

IOVS nov11 – IF 3.66 => article en libre accès : http://www.ncbi.nlm.nih.gov/pubmed/21948551
Registration number 2009-A01132-55 ANSM (French Health Authority)

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