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Florent Aptel, Philippe Denis, Jean-Francois J Rouland, Jean-Paul G Renard, Alain M Bron; Multicenter Clinical Trial of Ultrasonic Circular Cyclo Coagulation in glaucoma patients without previous filtering surgery. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):6128. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients with open-angle glaucoma naïve of previous filtering surgery.
Prospective non comparative interventional clinical study performed in 5 French glaucoma centers. Thirty eyes of 30 patients with open-angle glaucoma, intraocular pressure (IOP) > 21 mmHg and with no previous filtering glaucoma surgeries were sonicated with a therapy probe comprising 6 piezoelectric transducers. The 6 transducers were activated 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 > 5 mmHg with possible re-intervention and without hypotensive medications adjunction) 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 (p<0.05), from a mean preoperative value of 28.2 ± 7.2 mmHg (n= 3.6 hypotensive medications) to a mean value of 19.6 ± 7.9 mmHg at 12 months (n= 3.1 hypotensive medications and n= 1.2 procedures) (mean IOP reduction of 30%). Success was achieved in 66% of eyes (19/30) at 12 months (mean IOP reduction of 37% in these same eyes). No major intra- or post-operative complications occurred.
UC3 procedure is an effective and well-tolerated method to reduce intraocular pressure in patients with open-angle glaucoma without previous filtering surgery.
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