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Overview iTrack™ Molteno3®

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

TRABECULAR MESHWORK Up to 75% of outflow resistance may reside in the trabecular meshwork.

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.
SCHLEMM’S CANAL Up to 50% of decreased outflow facility may be caused by blockages within the canal. 50 %

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.
Pre-iTrack: canal is collapsed
Post-iTrack: canal is open
COLLECTOR CHANNELS Up to 90% of collector channels may be blocked in glaucomatous eyes 90 %

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.

REDEFINING THE TREATMENT OF MILD-MODERATE GLAUCOMA

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

I view the angle as the new conjunctiva, because I want to manipulate it today – but I also want to preserve tissue. We all know that there’s not a single glaucoma procedure that lasts forever. I want to be able to come back and treat the patient again.

Mark J. Gallardo, MD

iTrack™ achieves post-op
IOP in the low-teens

Mean IOP (mmHg), 24 MonthsiTrack and Phaco - baseline - 19.8mmHg iTrack and Phaco - 24 months - 13.2mmHg iTrack alone - baseline - 21.6mmHg iTrack alone - 24 months - 13.8mmHg iTrack + Phaco iTrack alone Mean IOP (mmHg), 24 Months Baseline 24 Months 13.2 mmHg 19.8 mmHg 13.8 mmHg 21.6 mmHg

1. Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clinical Ophthalmology. Vol 12. August 2018.

iTrack™ has been observed to reduce medication dependence

Mean Medications (n), 24 MonthsiTrack and Phaco - baseline - 2.5 iTrack and Phaco - 24 months - 1.3 iTrack alone - baseline - 3.0 iTrack alone - 24 months - 2.1 Mean Medications (n), 24 Months iTrack + Phaco iTrack alone Baseline 24 Months 2.1 3.0 1.3 2.5

1. Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clinical Ophthalmology. Vol 12. August 2018.

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

TRABECULAR MESHWORK Up to 75% of outflow resistance may reside in the trabecular meshwork.

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.
SCHLEMM’S CANAL Up to 50% of decreased outflow facility may be caused by blockages within the canal. 50 %

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.
Pre-iTrack: canal is collapsed
Post-iTrack: canal is open
COLLECTOR CHANNELS Up to 90% of collector channels may be blocked in glaucomatous eyes 90 %

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.

The history of iTrack™

References
1. Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm’s canal for the reduction of IOP via an ab-interno approach. Clinical Ophthalmology. Vol 12. August 2018. 
2. Körber N. Ab interno canaloplasty for the treatment of glaucoma: a case series study. Spektrum Augenheilkd (2018) 32:223227
3. Gallardo MJ, Supnet RA, Ahmed IIK. Circumferential Viscodilation of Schlemms Canal for Open-Angle Glaucoma: ab-interno vs ab-externo canaloplasty with tensioning suture. Clinical Ophthalmology 2018:12 24932498.
4. Lubeck DM, Singh IP, Noecker RJ. Evaluation of Endothelial Cell Density and Loss Following iTrack Ab-Interno Canal Based Surgery. ASCRS 2020 (Paper Presentation). https://​ascrs​.con​fex​.com/​ascrs…
5. 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).
6. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322.
7. 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.
8. 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.
9. Fellman RL, Grover DS. Episcleral venous fluid wave: intraoperative evidence for patency of the conventional ouflow system. J Glaucoma. 2014;23(6):347 – 350.
10. 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.
11. 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.
12. 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
13. 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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