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EyeOP1 as a novel non‐invasive surgical treatment of glaucoma: an Italian multicenter study
Author(s) -
Giannaccare G.,
Bagnis A.,
Gizzi C.,
Vagge A.,
Fresina M.,
Del Noce C.,
Sebastiani S.,
Dormi A.,
Traverso C.E.,
Campos E.
Publication year - 2016
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2016.0450
Subject(s) - medicine , glaucoma , acetazolamide , intraocular pressure , ophthalmology , open angle glaucoma , ultrasound , glaucoma medication , anesthesia , radiology
Purpose To evaluate safety and efficacy of a new non‐invasive ultrasound device for the surgical treatment of glaucoma. Methods This is a multicenter prospective study conducted at the University of Bologna and Genoa including 30 eyes of 30 patients with uncontrolled glaucoma. Of these, 15 patients were affected by primary open angle glaucoma (POAG), 10 by angle closure glaucoma (ACG) and 5 by neovascular glaucoma (NVG). The procedure was performed by an ultrasound generator probe with 6 piezoeletric transducers activated for 4, 6 or 8 sec (EyeOP1, EyeTechCare, Rillieux‐la‐Pape, France). Intraocular pressure (IOP) measurements were performed before and 1 day, 1–2 weeks, 1–3–6 months after the procedure. Primary outcomes were mean IOP reduction, qualified success (IOP reduction ≥20% without hypotensive medication adjunction) and complete success (as above plus IOP < 21 mmHg). Secondary outcomes were the correlations with glaucoma subtypes and exposure treatment time. Results The mean pre‐operative IOP was 30.1 mmHg (mean numbers of hypotensive drops and acetazolamide tablets were 2.7 and 0.8 respectively). Six months after treatment, mean IOP value was 20.2 mmHg (mean number of hypotensive drops and acetazolamide tablets were 2 and 0.3 respectively). IOP reduction was significant regardless glaucoma subtypes and exposure time (p < 0.001). In particular, higher IOP reductions were found in patients affected by ACG or treated with 8 sec exposure time (always p < 0.05). Qualified success was reached in 18 eyes, complete success in 6 eyes. Two patients had no IOP reduction with the need of subsequent surgery or increased number of drops. No major complications occurred. Conclusions This procedure appear to be safe and effective in reducing IOP in all glaucoma subtypes. In particular, IOP reduction was shown to be higher in ACG and 8 sec exposure groups.