Overview

REDEFINING THE TREATMENT OF GLAUCOMA

Combining a process of 360° catheterization and pressurized viscodilation, iTrack™ is a stent-free glaucoma procedure that treats 360° of the conventional outflow pathway to effectively reduce IOP in open-angle glaucoma patients.¹ A reduction in medication burden has also been observed following iTrack™.¹

1. Lewis RA, von Wolff K, Tetz M, Koerber N, Kearney JR, Shingleton BJ, Samuelson TW. Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. J Cataract Refract Surg. 2011 Apr;37(4):682 – 90. doi: 10.1016/j.jcrs.2010.10.055. PMID: 21420593.

If we go back and look at our basic science series book and talk about outflow and resistance, we note that there’s disease throughout the entire continuum of the outflow system. It’s actually addressed when we viscodilate with the iTrack™ canaloplasty microcatheter.

Mark J. Gallardo, MD

iTRACK™ IS DESIGNED TO TREAT ALL SITES OF OUTFLOW RESISTANCE IN THE CONVENTIONAL OUTFLOW SYSTEM — BOTH PROXIMAL AND DISTAL

Up to 75% of outflow resistance is localized within the trabecular meshwork.¹ The juxtacanalicular portion of the trabecular meshwork, which lies immediately adjacent to Schlemm’s canal, is thought to account for the majority of reduced outflow facility within the trabecular meshwork of POAG eyes. iTrack™ can effectively separate the compressed trabecular plates within the trabecular meshwork.^3 – 5

1. Manik Goel, Renata G Picciani, Richard K Lee, and Sanjoy K Bhattacharya. Aqueous Humor Dynamics: A Review. Open Ophthalmol J. 2010; 4: 52 – 59.
2. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322.3. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504.4. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.

The dimensions of the lumen of Schlemm’s canal are smaller in POAG eyes¹ and can account for up to 50% of decreased outflow facility in POAG eyes.² iTrack™ can effectively break adhesions within Schlemm’s canal, in addition to dilating the canal up to twice its size.^3 – 5

1. Johnstone MA, Grant WG. Pressure-dependent changes in structures of the aqueous outflow system of human and monkey eyes. Am J Ophthalmol. 1973;75:365 – 383 2. Allingham RR, de Kater AW, Ethier CR. Schlemm’s canal and primary open angle glaucoma: correlation between Schlemm’s canal dimensions and outflow facility. Exp Eye Res. 1996;62(1):101 – 109. 3. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322. 4. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504. 5. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.

Up to 90% of collector channels may be blocked by herniations of the trabecular meshwork in POAG eyes.^1,2 These herniations into the collector channels result in increased outflow resistance.^1,2 iTrack™ can effectively push out herniations out of the collector channels and dilate the collector channels to reduce outflow resistance.^3 – 5

1. Gong H, et al. Reduction of the available area for Aqueous humor outflow and increase in meshwork herniations into collector channels following acute IOP elevation in bovine eyes. Invest. Ophthalmol Vis Sci 2008; 49:5346 – 5352. 2. Gong H and Francis A: Schlemm’s Canal and Collector Channels as Therapeutic Targets. In Innovations in Glaucoma Surgery, Samples JR and Ahmed I eds. Chapter 1, page 3 – 25, Springer New York, 2014.Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322. 3. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504. 4. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.

Visit the iTrack™ website
Glaucoma-iTrack.com

References
1. Lewis RA, von Wolff K, Tetz M. et al. Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. J. Cataract Refract. Surg. 37, 682 – 690 (2011).
2. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322.
3. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504.
4. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.
5. Fellman RL, Grover DS. Episcleral venous fluid wave: intraoperative evidence for patency of the conventional ouflow system. J Glaucoma. 2014;23(6):347 – 350.
6. Gong H, et al. Reduction of the available area for Aqueous humor outflow and increase in meshwork herniations into collector channels following acute IOP elevation in bovine eyes. Invest. Ophthalmol Vis Sci 2008; 49:5346 – 5352.
7. Gong H and Francis A: Schlemm’s Canal and Collector Channels as Therapeutic Targets. In Innovations in Glaucoma Surgery, Samples JR and Ahmed I eds. Chapter 1, page 3 – 25, Springer New York, 2014.
8. Allingham RR, de Kater AW, Ethier CR. Schlemm’s canal and primary open angle glaucoma: correlation between Schlemm’s canal dimensions and outflow facility. Exp Eye Research 1996;62:101 – 10
9. Maepea O, Bill A. Pressures in the juxtacanalicular tissue and Schlemm’s canal in monkeys. Exp Eye Res1992;54:879 – 883.

Indications: The iTrack™ canaloplasty microcatheter has been cleared for the indication of fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.

Contradictions: The iTrack™ canaloplasty microcatheter is not intended to be used for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in eyes of patients with the following conditions: neovascular glaucoma; angle closure glaucoma; and, previous surgery with resultant scarring of Schlemm’s canal.

Adverse events: Possible adverse events with the use of the iTrack™ canaloplasty microcatheter include, but are not limited to: hyphema, elevated IOP, Descemet’s membranedetachment, shallow or flat anterior chamber, hypotony, trabecular meshwork rupture, choroidal effusion, Peripheral Anterior Synechiae (PAS) and iris prolapse.

Warnings: The iTrack™ canaloplasty microcatheter is intended for one time use only. DO NOT re-sterilize and/or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

Precautions: The iTrack™ canaloplasty microcatheter should be used only by physicians trained in ophthalmic surgery. Knowledge of surgical techniques, proper use of the surgical instruments, and post-operative patient management are considerations essential to a successful outcome.

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