Ultrasonic circular cyclocoagulation prospective safety and effectiveness study.

PURPOSE: To evaluate the efficacy and safety of ultrasound cycloplasty procedures (UCP) in patients with uncontrolled glaucoma.
METHODS: Prospective longitudinal study with UCP was performed by EyeOP1© probe with 8 s duration on 6 or 8 sectors, according to baseline intraocular pressure (IOP). Complete ophthalmic examination was performed pre- and post-operatively at 1st day, 1st week, 1st, 3rd, 6th, 9th and 12th months. UCP was repeated beyond 3rd month if IOP was > 21 mmHg, under maximum therapy, without major complications. Primary outcomes were complete (IOP reduction ≥ 20% or reduction in number of antiglaucomatous drugs and IOP ≥ 5 mmHg without occurrence of major complications) and qualified (IOP reduction ≥ 20% or reduction in number of antiglaucomatous drugs and IOP ≥ 5 mmHg) surgical success rates at 12 months. Secondary outcomes were mean IOP reduction, mean number of drugs reduction, rates of failure, number of repeated procedures, mean time to failure and occurrence of complications.
RESULTS: Fourteen eyes of 13 patients (11 male) with advanced glaucoma (Hoddap classification) were included. Six were surgically naïve. Mean age was 68.29 ± 10.66 years. Four eyes were treated in 8 sectors (28.5%). Patients were followed for 12 months after first UCP procedure. Overall surgical success was achieved in 92.9% at 6 months and in 100% of cases at 12 months. Mean IOP significantly reduced from 28.50 ± 7.61 mmHg to 13.79 ± 6.97 at 1 month, 17.36 ± 8.58 at 3 months, 17.79 ± 6.29 at 6 months, 16.3 ± 4.6 at 9 months and to 15.23 ± 5.09 at 12 months (p < 0.01). Mean number of drugs reduced from 3.71 ± 0.61 to 2.43 ± 1.51 at 3 months, 2.86 ± 1.1 at 6 months, 2.64 ± 0.93 at 9 months and to 2.92 ± 0.86 at 12 months (p < 0.05). Major reversible complications included choroidal detachment in 2 (14.29%) and corneal edema in 1 eye (7.14%), without permanent visual acuity reduction. Minor reversible complications included anterior chamber reaction (92.25%), conjunctival hyperemia (71.43%) and superficial keratitis (57.4%). Four eyes (28.57%) had indication for repeating UCP, with mean period to failure of 8.1 ± 3.95 months.
CONCLUSION: UCP procedures are effective in reducing IOP in severe glaucoma. Its application and repetition seem to be a medium-long term acceptable alternative to cyclodestructive surgery. However, long-term efficacy and safety require yet further investigation.