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Acta Ophthalmol. 2016 Aug;94(5):e268-77. doi: 10.1111/aos.12913. Epub 2015 Nov 7.

Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery.

Author information

1
Department of Ophthalmology, University Hospital, CHU Grenoble, Joseph Fourier University, Grenoble, France.
2
Department of Ophthalmology, University Hospital, Lyon, France.
3
Department of Ophthalmology, Claude Huriez Hospital, CHRU de Lille, Lille, France.
4
Department of Ophthalmology, Val de Grace Military Hospital, Paris, France.
5
Department of Ophthalmology, University Hospital, CHU Dijon, Dijon, France.

Abstract

PURPOSE:

To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open-angle glaucoma naïve of previous filtering surgery.

METHODS:

Prospective non-comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open-angle glaucoma, intra-ocular pressure (IOP) > 21 mmHg and with no previous filtering glaucoma surgeries were sonicated with a probe comprising six piezoelectric transducers. The six transducers were activated with a 6-s exposure time. Complete ophthalmic examinations were performed before the procedure and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after the procedure. Primary outcomes were qualified surgical success (defined as IOP reduction from baseline ≥20% and IOP > 5 mmHg with possible re-intervention and without hypotensive medication adjunction) and complete surgical success (defined as IOP reduction from baseline ≥20%, IOP > 5 mmHg and IOP < 21 mmHg with possible re-intervention and without hypotensive medication adjunction) at the last follow-up visit and vision-threatening complications. Secondary outcomes were mean IOP at each follow-up visit compared with baseline, medication use, complications and re-interventions.

RESULTS:

Intra-ocular pressure was significantly reduced (p < 0.05) from a mean pre-operative value of 28.2 ± 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 ± 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Qualified success was achieved in 63% of eyes (19/30) (mean IOP reduction of 37% in these eyes) and complete success in 46.7% of eyes (14/30) (mean IOP reduction of 37% in these eyes) at the last follow-up. No major intra- or post-operative complications occurred.

CONCLUSIONS:

The UC(3) procedure seems to be an effective and well-tolerated method to reduce IOP in patients with open-angle glaucoma without previous filtering surgery.

KEYWORDS:

ciliary body; cyclocoagulation; glaucoma; ultrasound

PMID:
26547890
DOI:
10.1111/aos.12913
[Indexed for MEDLINE]
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