High-intensity Focused Ultrasound Treatment in Moderate Glaucoma Patients: Results of a 2-Year Prospective Clinical Trial

Abstract

Precis: Ultrasound Cyclo Plasty (UCP) treatment using high-intensity focused ultrasound (HIFU) is an effective and safe therapy to reduce intraocular pressure (IOP) in moderate glaucoma patients as was measured during a 2-year follow-up period. Purpose: The purpose of this study was to evaluate the long-term safety and efficacy of the UCP procedure using HIFU in moderate glaucoma patients. Patients and Methods: A prospective interventional noncomparative study was carried out. Fifteen patients (15 eyes) with moderate open-angle glaucoma were enrolled. All eyes were treated with UCP-HIFU. A thorough ophthalmic examination and IOP measurements were performed before the UCP-HIFU procedure and at 1 day, 1 week, 4 weeks, 3 months, 6 months, 1 year, and 2 years after the procedure. The primary outcome was defined as a surgical success (IOP reduction of 20% or ≥5 mm Hg) at the last follow-up visit. The secondary outcomes were the mean IOP at each follow-up visit, number of medications used, complications profile, and reinterventions. Results: The mean preoperative IOP at baseline was 26.8±5.0 mm Hg. All patients had a positive response and a lower IOP after treatment, with a relatively stable 31% reduction in IOP during the follow-up period. A significant reduction in IOP was observed at all postprocedure examination points (P<0.01), with a mean 17.6±4.4 mm Hg at 2 years after the procedure (P=0.005). Surgical success was achieved in 87% of the patients at their last follow-up visit. There was a nonsignificant decrease in the mean number of glaucoma medications from 2.5±0.8 to 2.0±1.0 at 2 years (P=0.48). No major intraoperative or postoperative complications were noted. Conclusion: UCP-HIFU treatment is an effective, safe, and well-tolerated method to reduce IOP in patients with moderate glaucoma.

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.…”

Ultrasound‐assisted ocular drug delivery: A review of current evidence

“…Ultrasound cycloplasty, a cyclodestructive procedure that reduces aqueous humor production by utilizing a ring probe to propagate focused ultrasound, defined as 21 MHz pulses given sequentially for 4, 6, or 8 s across the surface of the eye, has been shown to reduce IOP in patients with glaucoma without notable morbidity. 79 Interestingly, ultrasound cycloplasty appears to demonstrate greater IOP reduction in patients with higher preoperative IOP, suggesting it is particularly valuable for treating patients with advanced-stage glaucoma. In a separate 2-year prospective interventional noncomparative study evaluating ultrasound cycloplasty in 15 patients with moderate open-angle glaucoma, a stable and statistically significant reduction (p = 0.005) in IOP was observed at 2 years follow up without notable intraoperative or postoperative complications.…”

“…This successful outcome was presumed to be the result of focal damage to the ciliary epithelium. Ultrasound cycloplasty, a cyclodestructive procedure that reduces aqueous humor production by utilizing a ring probe to propagate high‐intensity focused ultrasound, defined as 21 MHz pulses given sequentially for 4, 6, or 8 s across the surface of the eye, has been shown to reduce IOP in patients with glaucoma without notable morbidity 79 . Interestingly, ultrasound cycloplasty appears to demonstrate greater IOP reduction in patients with higher preoperative IOP, suggesting it is particularly valuable for treating patients with advanced‐stage glaucoma.…”

The distribution of ultrasound cyclo plasty probe models in Chinese glaucoma patients

“…UCP procedure was registered in China in 2017. Studies have shown that this device utilizes high intensity focused ultrasound technology to cure glaucoma patients by partial coagulation necrosis of the ciliary body, with decent tolerance and curative effect [8][9][10][11][12]. Compared with the above surgical methods, the EyeOP1 treatment has the advantages of non-invasive, precise positioning, effectively reducing intraocular pressure, fewer complications and lower pain score [13][14][15].…”