Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results
- 419 Downloads
To report 3-year results investigating the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation of Schlemm’s canal and tensioning of the inner canal wall to treat open-angle glaucoma.
This was a prospective, multi-center, interventional study of 109 eyes of 109 adult, open-angle glaucoma patients undergoing canaloplasty or combined cataract-canaloplasty surgery. Qualifying preoperative intraocular pressures (IOP) were at least 16 mmHg with historical IOPs of at least 21 mmHg with or without medical therapy. A flexible microcatheter was used to viscodilate the full circumference of the canal and to place a trabecular tensioning suture. Primary outcome measures included IOP, glaucoma medication usage, and adverse events.
Eyes with canaloplasty showed a mean baseline IOP of 23.0 ± 4.3 mmHg and mean glaucoma medication usage of 1.9 ± 0.7 medications, which decreased to a mean IOP of 15.1 ± 3.1 mmHg on 0.9 ± 0.9 medications at 3 years postoperatively. Eyes with combined cataract-canaloplasty surgery showed a mean baseline IOP of 24.3 ± 6.0 mmHg on 1.5 ± 1.2 medications, which decreased to a mean IOP of 13.8 ± 3.2 mmHg on 0.5 ± 0.7 medications at 3 years. Intraocular pressure and medication use results for all study eyes were significantly decreased from baseline (p <0.00001) at all intervals. Late postoperative complications included cataracts (19.1%) and transient IOP elevation (1.8%).
Canaloplasty demonstrated significant and sustained IOP reductions accompanied by an excellent short- and long-term safety profile in adult patients with open-angle glaucoma.
KeywordsCanaloplasty Microcatheter Non-penetrating glaucoma surgery Open-angle glaucoma Schlemm’s canal
The authors would like to recognize Dr. Robert Stegmann, Pretoria, South Africa, who was instrumental in the development of canaloplasty.
The sponsor, iScience Interventional Corporation, Menlo Park, California, participated in the design of the study, data monitoring, and data management. The authors have full control of all primary data and agree to allow Graefe’s Clinical and Experimental Ophthalmology to review the data if requested.
Conflict of Interest
Dr. Tetz acknowledges a consulting agreement with iScience Interventional Corporation. Dr. Koerber, Dr. von Wolff, and Dr. Bull have no conflicting interests to disclose.
- 2.Sanchez E, Schnyder CC, Sickenberg M, Chiou AG, Hediguer SE, Mermoud A (1996–1997) Deep sclerectomy: results with and without collagen implant. Int Ophthalmol 20:157–62Google Scholar
- 5.Kearney JR, Ball SF, Field MW, Cameron BD (2006) Circumferential viscodilation of Schlemm’s canal with a flexible microcannula during non-penetrating glaucoma surgery. Digit J Ophthalmol 12:1–9Google Scholar
- 6.Lewis RA, von Wolff K, Tetz M, Koerber N, Kearney JR, Shingleton B, Samuelson TW (2007) Canaloplasty: circumferential viscodilation and tensioning of Schlemm's canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: interim clinical study analysis. J Cataract Refract Surg 33:1217–1226PubMedCrossRefGoogle Scholar
- 7.Lewis RA, von Wolff K, Tetz M, Koerber N, Kearney JR, Shingleton B, Samuelson TW (2009) 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. J Cataract Refract Surg 35:814–824PubMedCrossRefGoogle Scholar
- 8.Grieshaber MC, Fraenkl S, Schoetzau A, Flammer J, Orgül S (2010) Circumferential viscocanalostomy and suture canal distension (canaloplasty) for whites with open-angle glaucoma. J Glaucoma (Epub ahead of print)Google Scholar
- 10.Altman DG (1991) Practical statistics for medical research. Chapman & Hall, Boca Raton, FL, pp 241–265Google Scholar
- 11.Fahrmeir L, Tutz G (2001) Multivariate statistical modeling based on generalized linear models, 2nd edn. Springer, Berlin Heidelberg New York, pp 260–297Google Scholar