Using proprietary microcatheter technology, iTrack™ is a true 360° minimally invasive glaucoma surgery (MIGS) that addresses the entire conventional outflow pathway, including the trabecular meshwork, Schlemm’s canal and the collector channels. It does not remove or damage tissue and does not require a permanent stent or implant. As an added benefit, iTrack™ is cleared for use as a standalone procedure and in combination with cataract surgery.

Tick
  • Stent-Free MIGS Procedure
  • Minimal endothelial cell loss (-3.2%)*
  • 30% average IOP reduction
  • Minimally traumatic to delicate eye tissue
  • Standalone or Combined Procedure
* (D.M. Lubeck, MD, and R.J. Noecker, MD, unpublished data, 2021; accepted for presentation at ASCRS 2021).

What does iTrack™ do differently to other MIGS devices?

Rather than attempt to mechanically change or bypass the pathway of aqueous outflow, iTrack™ acts to re-establish the natural aqueous flow throughout 360° of the conventional outflow pathway. Akin to angioplasty of the eye, iTrack™ combines a process of catheterization and viscodilation to address all potential points of blockage in the trabecular meshwork, Schlemm’s canal and the collector channels.

iTrack™ comprehensively treats outflow locations, which is why it is my first go-to MIGS procedure. I don’t have the diagnostic capability to know where the obstruction is located or what level of resistance exists, and so I like to start off with a MIGS that addresses everything.

1

TRABECULAR MESHWORK

Up to 75% of the resistance to aqueous humor outflow is localized within the trabecular meshwork.

iTrack™ separates the compressed trabecular plates of the trabecular meshwork and creates microperforations into the anterior chamber.


2

SCHLEMM’S CANAL

Narrow or collapsed Schlemm’s canal correlates with a decrease in outflow facility by as much as 50% in POAG eyes.

iTrack™ mechanically breaks adhesions within Schlemm’s canal and dilates the canal by up to 2 – 3 times via a process of pressurized viscodilation. 


3

COLLECTOR CHANNELS

Up to 90% of collector channels may be blocked by herniated trabecular meshwork in POAG eyes.

iTrack™ reduces herniations in the collector channels via a process of pressurized viscodilation. 

What are the potential benefits of stent-free MIGS?

When it comes to MIGS, preserving tissue is important. So, too, is the ability to preserve natural aqueous flow through the conventional outflow pathway. The use of stent based MIGS, which disrupt natural aqueous flow by attempting to bypass the conventional outflow system via one or more points, create artificial flow. This artificial flow may result in excessive damage to the corneal endothelium. Specifically, it has been suggested that altering aqueous currents to one point of exit may damage the corneal endothelium, leading to endothelial cell loss (ECL). By targeting the entire circumference of the conventional outflow pathway, iTrack™ may limit the risk of ECL. In a 5‑year prospective multi-center study evaluating endothelial cell density (ECD) in eyes undergoing canaloplasty in combination with cataract surgery, interim 12-month results demonstrate a mean change in ECD of ‑3.2% (SD ±9.0%) (D.M. Lubeck, MD, and R.J. Noecker, MD, unpublished data, 2021; accepted for presentation at ASCRS 2021). 

MIGS stents like iStent and Hydrus Microstent create preferential outflow in one area of the angle, so the same risks seen with traditional incisional glaucoma surgeries may potentially occur with MIGS procedures utilizing stents…

Why should MIGS devices spare, and not tear, the trabecular meshwork?

Glaucoma is a chronic, progressive disease that has no cure. To that end, the preservation of tissue to enable future treatment intervention is an important consideration. iTrack™ uses a combination of 360° catheterization and pressurized viscodilation to reduce IOP, without removing trabecular meshwork tissue. Indeed, iTrack™ preserves both the conjunctiva and angle for future procedures, if required. iTrack™ has also been shown to minimize complications associated with postoperative inflammation. In contrast, MIGS procedures that are tissue-destructive, such as goniotomy, can result in significant inflammation that may compromise the health of the cornea, leading to ECL.

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.

How does iTrack™ outperform the other MIGS devices?

By comprehensively addressing all resistance sites in the conventional outflow pathway, including the collector channel ostia, iTrack™ has demonstrated a mean reduction in IOP at 24 months ranging from 13.2 mmHg when performed as a standalone procedure, to 13.8 mmHg when performed in combination with cataract surgery. It also reduces medication dependence in the majority of patients.

Gallardo, MJ. 24-Month Efficacy of Viscodilation of Schlemm’s Canal and the Distal Outflow System with iTrack Ab-Interno Canaloplasty for the Treatment of Primary Open-Angle Glaucoma. Clinical Ophthalmology 2021:15 1591 –1599.
Standalone IOP baseline (mmHg) Standalone IOP last follow up (mmHg) Combined with cataract surgery IOP baseline (mmHg) Combined with cataract surgery IOP last follow up (mmHg)
iTrack
Gallardo, 36 Months (1) 21.1 ± 5.2
(N=43)
13.4 ± 2.1
(N=25)
19.5 ± 3.7
(N=37)
13.3 ± 2.1
(N=26)
Gallardo, 24 Months (2) 21.6±5.7
(N=31)
13.8±3.1
(N=31)
19.8±3.9
(N=29)
13.2±2.1
(N=29)
Mueller et al, 24 Months (3) - - 20.24 ± 5.92
(N=25)
13.67 ± 2.15
(N=21)
iStent
Vold et al at, 36 Months (4) 25.5 ± 2.5
(N=54)
14.6
(N=34)
- -
Hengerer et al, 36 Months (5) - - 22.6 ± 6.2
(N=81)
14.3 ± 1.7
(N=41)
KDB
Arnljots et al, 20 – 29 months (6) 22.2 ± 5.8
(N=13)
15.9 ± 4.3
(N=13)
24.2 ± 6.8
(N=19)
16.2 ± 6.7
(N=19)

1. Gallardo, MJ, MD, unpublished data, 2020; accepted for presentation at ASCRS 2021.

2. Gallardo, MJ. 24-Month Efficacy of Viscodilation of Schlemm’s Canal and the Distal Outflow System with iTrack Ab-Interno Canaloplasty for the Treatment of Primary Open-Angle Glaucoma. Clinical Ophthalmology 2021:15 1591 – 1599.

3. Kazerounian S, Zimbelmann M, Lörtscher M, Hommayda S, Tsirkinidou I, Müller M. Canaloplasty ab interno (AbiC) — 2‑Year-Results of a Novel Minimally Invasive Glaucoma Surgery (MIGS) Technique. Klin Monbl Augenheilkd. 2020 Nov 17. English, German. doi: 10.1055/a‑1250 – 8431. Epub ahead of print. PMID33202434.

4. Vold SD, Voskanyan L, Tetz M, et al. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmology and Therapy. 2016;5(2):161 – 172. doi:10.1007/s40123-01600653

5. Hengerer FH, Auffarth GU, Riffel C, Conrad-Hengerer I. Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma. Ophthalmology and Therapy. 2018;7(2):405 – 415. doi:10.1007/s40123-01801528

6. Arnljots TS, Economou MA. Kahook Dual Blade Goniotomy vs iStent inject: Long-Term Results in Patients with Open-Angle Glaucoma. Clin Ophthalmol. 2021 Feb 11;15:541 – 550. doi: 10.2147/OPTH.S284687. PMID: 33603332; PMCIDPMC7884935.

Why is iTrack™ the superior canaloplasty device?

Introduced in 2008 and with more than 150,000 procedures performed globally, iTrack™ is the world’s first canaloplasty microcatheter. It is also the only canaloplasty device that enables surgeons to customize the amount of viscodilation for each patient. Despite measuring just 250 microns, the iTrack™ comprises an infusion pathway for the delivery of ophthalmic viscosurgical device or OVD, a proprietary guidewire that controls how the microcatheter tracks, and a fiber optic for illuminating the distal tip. It also delivers +100 microliters of OVD over the entire 360º of Schlemm’s canal via a process of pressurized viscodilation.

Pressurized Viscodilation

iTrack™ features a patented, pressurized mechanism (Patent No. US7,967,772,B2) that delivers OVD into Schlemm’s canal at a rate of pressure 3x greater than OMNI®.* 

OMNI® delivers small amounts of OVD at a lower rate of pressure, as compared to iTrack.*

+100 Microliters of OVD

iTrack™ delivers +100 microliters of OVD** over 360° of Schlemm’s canal to expand and dilate the canal, and to improve flow through the episcleral venous system. 
OMNI® delivers 5.5 microliters of OVD over 180° of the canal. 

Surgeon Controlled OVD Delivery

iTrack™ enables titration of OVD volume based on the patient’s pathology. 
OMNI® delivers OVD via a continuous delivery mechanism; OVD volume cannot be adjusted. 

Single-Pass 360° Catheterization

With a patented flexible design and internal guidewire, iTrack™ is the only canaloplasty device that can catheterize 360° of the canal during a single intubation. 
In contrast, OMNI® can only catheterize the canal in 180° segments; it must be withdrawn and reinserted via the goniotomy site in order to intubate the remaining 180° of the canal. 

Illuminated Fiber Optic Tip

The patented fiber optic tip of the iTrack™ provides continuous location feedback to prevent misdirection into the suprachoroidal space or CC ostia. 
OMNI® does not have an illuminated fiber optic tip. 

Tissue-Sparing

iTrack™ does not remove tissue and preserves the angle, thus enabling future treatments. 
OMNI® removes trabecular meshwork tissue and may hinder the effectiveness of future treatments. It also introduces a higher risk of complications.1,2,3 

* In-house testing (Nova Eye Medical) using a water column to model eye pressure, interchangeable with both the iTrack™ canaloplasty microcatheter and the OMNI surgical system, and using a transducer to measure pressure (psi, pounds per square inch) at the microcatheter tip. Data available upon request.

**In-house testing (Nova Eye Medical) using a robotically controlled ViscoInjector™ with time-recording mass data to simulate the delivery of OVD over 360° of Schlemm’s canal. Data available upon request.

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. https://​doi​.org/​10​.​2147/ OPTH.S177597.

2. Vold SD, Williamson BK, Hirsch L, Aminlari AE, Cho AS, Nelson C, Dickerson JE, Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: the ROMEO Study, OPHTHALMOLOGY GLAUCOMA (2020)

3. Hirsch, Louis MD; Cotliar, Jeremy MD; Vold, Steven MD; Selvadurai, Deepan MD; Campbell, Anita G MD; Ferreira, Gabriel MD; Aminlari, Ardalan MD; Cho, Andrew MD; Heersink, Sebastian MD; Hochman, Michael MD; Gallardo, Mark MD; Williamson, Blake MD; Phan, Ryan MD; Nelson, Cade BS; Dickerson, Jaime E. PhD. Canaloplasty and Trabeculotomy ab interno with the OMNI System Combined with Cataract Surgery in Open-Angle Glaucoma, Journal of Cataract & Refractive Surgery: December 09, 2020 — Volume Publish Ahead of Print ‑Issue — doi: 10.1097/

iTrack™ Indication For Use 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. OMNI® Indication For Use The OMNI® Surgical System has been cleared for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure (IOP) in adult patients with primary open – angle glaucoma. OMNI is a registered trademark of Sight Sciences.

Mean IOP Reduction at 12 Months

n Baseline Post-op
iTrack
Standalone (1) 41 21.2 mmHg 13.7 mmHg
OMNI
Standalone, Baseline IOP >18 mmHg (2) 24 21.8 mmHg 15.6 mmHg
Standalone, Baseline IOP 18 mmHg (2) 24 15.4 mmHg 13.9 mmHg
iTrack
Combined CE (1) 34 19.4 mmHg 13.0 mmHg
OMNI
Combined CE, Baseline IOP >18 mmHg (3) 24 21.9 mmHg 15.1 mmHg
Combined CE, Baseline IOP 18 mmHg (3) 54 14.1 mmHg 13.4 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. https://​doi​.org/​10​.​2147/ OPTH.S177597. 2. Vold SD, Williamson BK, Hirsch L, Aminlari AE, Cho AS, Nelson C, Dickerson JE, Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: the ROMEO Study, OPHTHALMOLOGY GLAUCOMA (2020) 3. Hirsch, Louis MD; Cotliar, Jeremy MD; Vold, Steven MD; Selvadurai, Deepan MD; Campbell, Anita G MD; Ferreira, Gabriel MD; Aminlari, Ardalan MD; Cho, Andrew MD; Heersink, Sebastian MD; Hochman, Michael MD; Gallardo, Mark MD; Williamson, Blake MD; Phan, Ryan MD; Nelson, Cade BS; Dickerson, Jaime E. PhD. Canaloplasty and Trabeculotomy ab interno with the OMNI System Combined with Cataract Surgery in Open-Angle Glaucoma, Journal of Cataract & Refractive Surgery: December 09, 2020 — Volume Publish Ahead of Print ‑Issue — doi: 10.1097/

Medication Reduction at 12 Months

n Baseline Post-op
iTrack
Standalone (1) 41 3.2 1.4
OMNI
Standalone, Baseline IOP >18 mmHg (2) 24 1.7 1.2
Standalone, Baseline IOP <18 mmHg (2) 24 2.0 1.3
iTrack
Combined CE (1) 34 2.6 0.9
OMNI
Combined CE, Baseline IOP >18 mmHg (3) 24 2.0 1.1
Combined CE, Baseline IOP <18 mmHg (3) 54 1.6 0.9
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. https://​doi​.org/​10​.​2147/ OPTH.S177597. 2. Vold SD, Williamson BK, Hirsch L, Aminlari AE, Cho AS, Nelson C, Dickerson JE, Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: the ROMEO Study, OPHTHALMOLOGY GLAUCOMA (2020) 3. Hirsch, Louis MD; Cotliar, Jeremy MD; Vold, Steven MD; Selvadurai, Deepan MD; Campbell, Anita G MD; Ferreira, Gabriel MD; Aminlari, Ardalan MD; Cho, Andrew MD; Heersink, Sebastian MD; Hochman, Michael MD; Gallardo, Mark MD; Williamson, Blake MD; Phan, Ryan MD; Nelson, Cade BS; Dickerson, Jaime E. PhD. Canaloplasty and Trabeculotomy ab interno with the OMNI System Combined with Cataract Surgery in Open-Angle Glaucoma, Journal of Cataract & Refractive Surgery: December 09, 2020 — Volume Publish Ahead of Print ‑Issue — doi: 10.1097/

Complications/​Adverse Events

iTrack Standalone and Combined CE Procedure (1)

Intraoperative bleeding at gonio site (n not specified)

Transient postoperative microhyphema (n not specified)
OMNI Standalone Procedure (2)

Mild AC inflammation, 6 (12.5%)

Posterior capsule opacity, 5 (10.4%)

IOP Increase ≥ 10 mmHg above baseline > 30 days postoperative, 3 (6.3%)

Cystoid macular edema, 2 (4.2%)

Comeal edema, 2 (4.2%)

Hyphema > 1mm, 2 (4.2%)


Combined CE Procedure
(3)

Mild AC inflammation, 8 (9.9%)

Posterior capsule opacity, 14 (17.3%)

IOP Increase ≥ 10 mmHg above baseline > 30 days postoperative, 3 (3.7%)

Cystoid macular edema, 4 (4.9%)

Comeal edema, 4 (4.9%)

Hyphema > 1mm, 3 (3.7%)

Cyclodialysis, 1 (1.2%)

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. https://​doi​.org/​10​.​2147/ OPTH.S177597.2. Vold SD, Williamson BK, Hirsch L, Aminlari AE, Cho AS, Nelson C, Dickerson JE, Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: the ROMEO Study, OPHTHALMOLOGY GLAUCOMA (2020)3. Hirsch, Louis MD; Cotliar, Jeremy MD; Vold, Steven MD; Selvadurai, Deepan MD; Campbell, Anita G MD; Ferreira, Gabriel MD; Aminlari, Ardalan MD; Cho, Andrew MD; Heersink, Sebastian MD; Hochman, Michael MD; Gallardo, Mark MD; Williamson, Blake MD; Phan, Ryan MD; Nelson, Cade BS; Dickerson, Jaime E. PhD. Canaloplasty and Trabeculotomy ab interno with the OMNI System Combined with Cataract Surgery in Open-Angle Glaucoma, Journal of Cataract & Refractive Surgery: December 09, 2020 — Volume Publish Ahead of Print ‑Issue — doi: 10.1097/

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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. Gallardo, MJ. 24-Month Efficacy of Viscodilation of Schlemm’s Canal and the Distal Outflow System with iTrack Ab-Interno Canaloplasty for the Treatment of Primary Open-Angle Glaucoma. Clinical Ophthalmology 2021:15 1591 –1599. Kazerounian S, Zimbelmann M, Lörtscher M, et al. Canaloplasty ab interno (AbiC) — 2 Year-Results of a Novel Minimally Invasive Glaucoma Surgery (MIGS) Technique. Klinische Monatsblatter fur Augenheilkunde. 2020 Nov. DOI: 10.1055/a 1250 – 8431. D.M. Lubeck, MD, and R.J. Noecker, MD, unpublished data, 2020; accepted for presentation at ASCRS 2021. Manik Goel, Renata G Picciani, Richard K Lee, and Sanjoy K Bhattacharya. Aqueous Humor Dynamics: A Review. Open Ophthalmol J. 2010; 4: 52 – 59. 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 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. 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. 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 Gallardo, MJ, MD, unpublished data, 2020; accepted for presentation at ASCRS 2021. Kazerounian S, Zimbelmann M, Lörtscher M, Hommayda S, Tsirkinidou I, Müller M. Canaloplasty ab interno (AbiC) — 2‑Year-Results of a Novel Minimally Invasive Glaucoma Surgery (MIGS) Technique. Klin Monbl Augenheilkd. 2020 Nov 17. English, German. doi: 10.1055/a‑1250 – 8431. Epub ahead of print. PMID33202434. Vold SD, Voskanyan L, Tetz M, et al. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmology and Therapy. 2016;5(2):161 – 172. doi:10.1007/s40123-01600653 Hengerer FH, Auffarth GU, Riffel C, Conrad-Hengerer I. Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma. Ophthalmology and Therapy. 2018;7(2):405 – 415. doi:10.1007/s40123-01801528 Arnljots TS, Economou MA. Kahook Dual Blade Goniotomy vs iStent inject: Long-Term Results in Patients with Open-Angle Glaucoma. Clin Ophthalmol. 2021 Feb 11;15:541 – 550. doi: 10.2147/OPTH.S284687. PMID: 33603332; PMCIDPMC7884935.
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