Background: Ciclo plasty using high-intensity focused ultrasound (HIFU) technology acts through the selective coagulation of the ciliary body. Our aim was to evaluate the safety and efficacy profiles of 8-s probe HIFU cyclocoagulation using the EyeOP1 device.
Methods: Prospective pragmatic trial.
Inclusion criteria: adult glaucoma patients with uncontrolled IOP despite optimised medical therapy, and/or intolerant to medical therapy required to achieve target IOP.
Primary outcome: surgical success defined as IOP reduction from baseline >20% with final IOP ≤21 mmHg, without adding any IOP-lowering drugs, and without loss of light perception; or decreased use of IOP-lowering drugs with stable/decreased IOP, without loss of light perception.
Secondary outcomes: mean IOP, intra and postoperative complications, best-corrected visual acuity (BCVA) and number of IOP-lowering drugs at each visit. Outcome data were collected preoperatively and at postoperative day 1, and months 1, 3, 6 and 12.
Results: Forty-nine eyes of forty-nine patients (28 male) with a mean age of 70 ± 14 years were enroled. Pre-operative IOP was 26.9 ± 7.4 mmHg under 2.8 ± 0.9 topical medications, decreasing to 17.8 ± 6.4 mmHg under 2.3 ± 1 drugs at 12 months (p < 0.01). One-year surgical success was achieved in 71.4% of patients (IOP-reduction criteria: 59.2%; decreased use of IOP-lowering drugs: 38.8%). Eight patients were ultimately submitted to other glaucoma surgical interventions. Five patients experienced serious adverse events (loss of light perception n = 5; hypotony n = 1).
Conclusions: This innovative non-invasive technology seems to be effective in decreasing IOP and/or the number of administered drops in patients with refractory glaucoma. It seems a valuable tool to delay or preclude the need for filtering procedures in the majority of the patients.