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Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results

  • Glaucoma
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Background

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.

Methods

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.

Results

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%).

Conclusions

Canaloplasty demonstrated significant and sustained IOP reductions accompanied by an excellent short- and long-term safety profile in adult patients with open-angle glaucoma.

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Acknowledgements

The authors would like to recognize Dr. Robert Stegmann, Pretoria, South Africa, who was instrumental in the development of canaloplasty.

Financial Support

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.

Author information

Authors and Affiliations

  1. Augen-Tagesklinik Gross Pankow, Pankeweg 15, 16928, Gross Pankow, Germany

    Holger Bull & Kurt von Wolff

  2. Augencentrum Porz, Cologne, Germany

    Norbert Körber

  3. Eye Center Spreebogen, Berlin Eye Research Institute (BERI), Berlin, Germany

    Manfred Tetz

Authors
  1. Holger Bull
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  2. Kurt von Wolff
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  3. Norbert Körber
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  4. Manfred Tetz
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Corresponding author

Correspondence to Kurt von Wolff.

Additional information

Clinical trial registration site and number: http://www.controlled-trials.com/ISRCTN12425531; ISRCTN12425531

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Bull, H., von Wolff, K., Körber, N. et al. Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results. Graefes Arch Clin Exp Ophthalmol 249, 1537–1545 (2011). https://doi.org/10.1007/s00417-011-1728-3

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  • DOI: https://doi.org/10.1007/s00417-011-1728-3

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