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.
OBJECTIVE
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).


METHODS
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.


CONCLUSIONS
Canaloplasty was safe and effective in reducing IOP in adult patients with OAG.
Lewis
Richard A
RA
Private practice, Sacramento, California, USA. rlewiseyemd@yahoo.com
von Wolff
Kurt
K
Tetz
Manfred
M
Koerber
Norbert
N
Kearney
John R
JR
Shingleton
Bradford J
BJ
Samuelson
Thomas W
TW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000869:Anterior Eye Segment / Q000000981:diagnostic imaging / Q000601:surgery*; D002404:Catheterization; D005260:Female; D018463:Filtering Surgery / Q000379:methods*; D005902:Glaucoma, Open-Angle / Q000601:surgery*; D006068:Gonioscopy; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007429:Intraocular Pressure; D008297:Male; D033401:Microscopy, Acoustic; D008875:Middle Aged; D011126:Polypropylenes; D011446:Prospective Studies; D013536:Suture Techniques; D013537:Sutures; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage*; D014792:Visual Acuity
D011126:Polypropylenes; D055675:Viscosupplements; D006820:Hyaluronic Acid