A 2-year prospective multicenter study of ultrasound cyclo plasty for glaucoma

Abstract

Ultrasound cyclo plasty (UCP) is a recently developed surgical technique for glaucoma allowing a selective and controlled coagulation of the ciliary body. We herein investigated the long-term efficacy and safety of UCP for the treatment of glaucoma. This prospective study included patients with primary and secondary glaucoma. All surgeries were performed using the EyeOP1 device (Eye Tech Care, Rillieux-la-Pape, France). Sixty-six patients were included, and 60 completed regularly the 2-year follow-up. Preoperative IOP was 28.5 ± 9.6 mmHg and significantly decreased to 17.0 ± 5.4 at 2 years (p < 0.001). The daily number of both hypotensive eye drops and acetazolamide tablets decreased significantly (respectively, from 2.6 ± 1.1 to 1.7 ± 1.2 and from 0.7 ± 0.8 to 0.2 ± 0.5; both p < 0.001). At 2 years, 68.1% of patients met the definition of qualified success (IOP < 21 mmHg regardless of glaucoma medications) and 10.3% of patients met the definition of complete success (IOP < 21 mmHg without glaucoma medications). No major intra- or postoperative complications occurred; however, 15 eyes required additional glaucoma surgery. These results suggest that UCP is an effective and safe procedure to reduce IOP in glaucoma patients through a 2-year follow-up period.

Ultrasound Cyclo Plasty for Treatment of Surgery-Naïve Open-Angle Glaucoma Patients: A Prospective, Multicenter, 2-Year Follow-Up Trial

“…The mean number of medications was similar from baseline until the last follow up visit, and, again, these findings agreed with previous reports [19][20][21][22][23][24][25][26][27][28].…”

“…In our population, the mean ± SD baseline IOP was 24.3 ± 2.9 mmHg, and 24 months after, at the last follow up visit, the mean ± SD IOP was 15.9 ± 3.6 mmHg. Previous published literature has reported a lowering percentage ranging from 28% to 38% after 1 year [20,21], from 40% to 42% after 2 years [23][24][25], and of 33% at 3 years [26]. In particular, in our study, the IOP decrease was maximal at 1 to 3 months after the treatment and then tended to stabilize.…”

“…The possibility of retreating patients after a first UCP procedure with greater lowering in IOP has also been described [23,27,28], but in our study, patients were not retreated, except for a patient who experienced an IOP spike at M3 and glaucoma progression until vision loss. The patient experienced pseudoexfoliative glaucoma with advanced damage (Cup/Disk ratio 0.9).…”

“…Mydriasis was verified in seven patients and resolved spontaneously after 6 months. Scleral marks were observed in 24/66 eyes during follow-up (36%), although this was not considered to be a complication and has been reported in literature without signs of inflammation or scleral protrusion [16,23,27]. Using OCT, a transient scleral thickening that reduced spontaneously to its initial value has been described [29].…”

“…There is published evidence of the possibility of retreating patients with early and late IOP increase with a second UCP procedure to achieve a greater IOP decrease while maintaining the same safety profile as the first procedure [23,27,28]. Additionally, a new version of the probe is now available, allowing an increased circumference of treated ciliary body (eight or ten instead of six sectors treated); this device achieved significant IOP control with a reduction in medication number in the Chinese population [33,34].…”