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Florent Aptel, Philippe Denis, Jean-François Rouland, Jean-Philippe Nordmann, Yves Lachkar, Jean-Paul Renard, Eric Sellem, Christophe Baudouin, Alain M Bron; Multicenter Clinical Trial of Ultrasonic Circular Cyclo Coagulation in patients with Open-Angle Glaucoma: One Year Results. Invest. Ophthalmol. Vis. Sci. 2014;55(13):6170. doi: https://doi.org/.
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To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure with one year of follow-up.
Prospective non comparative interventional clinical study performed in 9 French glaucoma centers. Fifty-two eyes of 52 patients with open-angle glaucoma, intraocular pressure (IOP) > 21 mmHg, an average of 1.7 failed previous surgeries and an average of 3.7 hypotensive medications were insonified with a therapy probe comprising 6 piezoelectric transducers. The 6 transducers were activated, 24 patients (group 1) were treated with a 4 seconds exposure time for each shot and 28 patients (group 2) with a 6 seconds exposure time. Complete ophthalmic examinations were performed before the procedure, and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after. Primary outcomes were surgical success (defined as IOP reduction from baseline ≥ 20% and IOP > 5mmHg) at the last follow-up visit, and vision-threatening complications. Secondary outcomes were mean IOP at each follow-up visits compared to baseline, medication use, complications, and re-interventions.
IOP was significantly reduced in both groups (p<0.05), from a mean preoperative value of 30.3 ± 7.8 mmHg in group 1 and 29 ± 7.4 mmHg in group 2 to a mean value of 20.0 ± 6.9 mmHg in group 1 and 19.0 ± 6.7 mmHg in group 2 at last follow-up. Success (IOP reduction >20%) was achieved in 63.2% of eyes of the group 1 and 44% of eyes of the group 2 at last follow-up. Seven patients were ret-treated. No major intra- or post-operative complications occurred.
Ultrasonic Circular Cyclo Coagulation seems to be an effective and well-tolerated method to reduce intraocular pressure in patients with OAG. We found a lower efficacy with the higher dose.
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