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.confex.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.
The iTrack™ Advance has a CE Mark (Conformité Européenne) 2862 and US Food and Drug Administration (FDA) 510(k) #K221872 for the treatment of open-angle glaucoma.
— — — — — — — –
INDICATIONS (USA): The Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The Nova Eye iTrack™ Advance is indicated for the cutting or disruption of the trabecular meshwork during goniotomy procedures.*
The Nova Eye iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.
The ab interno surgical technique is not a cleared indication of the iTrack™ Advance in the USA.
* The iTrack™ Advance cutting function (goniotomy) is a Class 1 510(k) exempt device function that is not specifically indicated for the reduction of intraocular pressure (IOP) or the treatment of open-angle glaucoma.
CONTRAINDICATIONS (USA): The iTrack™ Advance 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; Previous surgery with resultant scarring of Schlemm’s canal.
PRECAUTIONS (USA): The iTrack™ Advance 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.
— — — — — — — –
INDICATIONS (International): The iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma.
CONTRAINDICATIONS (International): The iTrack™ Advance 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; Previous surgery with resultant scarring of Schlemm’s canal.
ADVERSE EVENTS (International): Possible adverse events with the use of the iTrack™ Advance include, but are not limited to: hyphema, elevated IOP, Descemet’s membrane detachment, shallow or flat anterior chamber, hypotony, trabecular meshwork rupture, choroidal effusion, Peripheral Anterior Synechiae (PAS) and iris prolapse.
PRECAUTIONS (International):: The iTrack™ Advance 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.
For full safety information, visit: https://itrack-advance.com
© 2025. Nova Eye, Inc. E&OE. Patents pending and/or granted.
iTrack™ Advance, iTrack™, ViscoInjector™ and iLumin™ are trademarks of Nova Eye, Inc.