Canaloplasty: Circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: Two-year interim clinical study results
Received 5 December 2008; received in revised form 19 January 2009; accepted 20 January 2009.
Purpose
To evaluate 2-year postsurgical safety and efficacy of canaloplasty (circumferential viscodilation and tensioning of the inner wall of Schlemm canal) to treat open-angle glaucoma (OAG).
Setting
Multicenter surgical sites.
Methods
This international prospective study comprised adult OAG patients having glaucoma surgery or combined glaucoma–cataract surgery. Qualifying preoperative intraocular pressure (IOP) was at least 16 mm Hg and historical IOP, at least 21 mm Hg. The full circumference of the canal was viscodilated and a trabecular tensioning suture placed with a microcatheter. Primary outcome measures included IOP and glaucoma medication use.
Results
At 24 months, all 127 eyes (127 patients) had a mean IOP of 16.0 mm Hg ± 4.2 (SD) and mean glaucoma medication use of 0.5 ± 0.8 (baseline values 23.6 ± 4.8 mm Hg and 1.9 ± 0.8 medications). Eyes with canaloplasty alone had a mean IOP of 16.3 ± 3.7 mm Hg and 0.6 ± 0.8 medications (baseline values 23.2 ± 4.0 mm Hg and 2.0 ± 0.8 medications). Eyes with combined glaucoma–cataract surgery had a mean IOP of 13.4 ± 4.0 mm Hg and 0.2 ± 0.4 medications (baseline values 23.1 ± 5.5 mm Hg and 1.7 ± 1.0 medications). The IOP and medication use results at all time points were statistically significant versus baseline (P <.001). The late postoperative follow-up identified 3 patients with elevated IOP. No other serious ocular or nonocular complications were reported.
Conclusion
Canaloplasty was safe and effective in reducing IOP in adult patients with OAG.
From private practices, Sacramento, California (Lewis), Johnstown, New York (Kearney), Boston, Massachusetts (Shingleton), and Minneapolis, Minnesota (Samuelson), USA; Augen-Tagesklinik Gross Pankow (von Wolff), Gross Pankow, Eye Center Spreebogen and Berlin Eye Research Institute (Tetz), Berlin, and Augen-op-Centrum (Koerber), Koeln, Germany
Corresponding author: Richard A. Lewis, MD, Grutzmacher & Lewis, 1515 River Park Drive, Suite 100, Sacramento, California 95815, USA.
Drs. Kearney, Lewis, Samuelson, Shingleton, and Tetz have consulting agreements with iScience Interventional. No author has a financial or proprietary interest in any material or method mentioned.
ABSTRACT