Assigned status Up to Date by Won I. Kim, MD on October 11, 2015.
Introduction and Background
Lowering intraocular pressure (IOP) is the only proven therapy for glaucoma. Traditional glaucoma filtration surgeries such as trabeculectomy, are highly successful in lowering IOP but have a very high rate of complications. This has led to the search for safer forms of glaucoma surgery. While surgeries like trabeculectomy seek to create a fistula that enables aqueous to be diverted from the anterior chamber into the subconjunctival space bypassing the natural outflow system, canaloplasty is a surgical technique that promotes outflow of aqueous via the natural outflow pathways through the trabecular meshwork (TM) and into Schlemm's canal (SC). It dilates SC with multiple direct injections of an ophthalmic viscoelastic device (OVD) administered in a controlled fashion through a flexible microcatheter that is threaded through the entire length of SC. To maintain this dilation, an intraluminal suture is placed within SC and tied tightly to apply a permanent tensioning effect. This not only keeps SC open and prevents its collapse but it also has the effect of putting the TM on stretch to make it more permeable to aqueous. Figures 1-3 Since filtration of aqueous is being directed into SC and the existing natural outflow pathways this should make this form of surgery unlikely to produce hypotony and all its related complications making it much safer than traditional glaucoma filtration surgeries.
Canaloplasty is a modification of viscocanalostomy, a form of non-penetrating glaucoma surgery. In this older technique, first introduced by Stegman and colleagues, OVD was injected into SC on either side of an external scleral dissection site with a metal cannula. Figure 4 The cannula, because it was not flexible, could only be extended into SC a limited distance and thus could only dilate a limited portion of the canal on either side of the dissection site. The injection of OVD caused an increase in SC dimensions leading to micro-ruptures in the inner wall of the canal, as well as adjacent TM. This created a direct connection between the anterior chamber and the lumen of the canal. The scleral flaps created to uncover SC were sutured watertight to avoid formation of a filtering bleb. Compared to trabeculectomy, viscocanalostomy proved to be a very safe procedure with fewer complications but its IOP lowering was inferior. Its long term efficacy was disappointing presumably due to eventual re-collapse of SC in the postoperative period.  Canaloplasty has the advantage of being able to dilate SC along its entire length utilizing a flexible microcatheter. It also has the advantage of using a permanent tensioning suture remaining in SC to maintain its dilation over time. Koerber reported a comparison of canaloplasty performed in one eye compared with viscocanalostomy in the contralateral eye. The viscocanalostomy eyes had a postoperative IOP of 16.1 +/- 3.9 on 0.4 +/- 0.5 medications with 35.7% complete success and 50% unqualified success. By contrast the canaloplasty eyes had an IOP of 14.5 +/- 2.6 on 0.3 +/- 0.5 medications with 60% complete success and 86.7% qualified success. 
Canaloplasty has several advantages over trabeculectomy. Under most circumstances, as long as goniopuncture is not performed, there is no bleb so bleb related complications are avoided. Hypotony and all its related complications can also be avoided under most circumstances since aqueous is allowed to drain via the natural outflow system so IOP should not be able to fall below episcleral venous pressure. Postoperative care and follow up is also simpler and less rigorous and visual recovery is typically more rapid. However, canaloplasty is also a more technically challenging surgery than trabeculectomy and typically does not produce IOP quite as low. It also scars an area of conjunctiva that may increase the risk of trabeculectomy failure in the future if it should be needed.
Indications and Contraindications
Indications: Canaloplasty is generally for open angle glaucomas. It is especially good for young patients with a clear lens and is less likely to cause cataract progression. It should also be considered for high myopes who would be at high risk for hypotony with a trabeculectomy surgery. It would also be excellent in ahakic patients where vitreous may obstruct the sclerotomy or tube in traditional glaucoma filtration surgeries.
Some relative contraindications include congenital glaucomas, narrow angle, angle recession, and cases with elevated episcleral venous pressure. An absolute contraindication would be angle closure glaucoma.
Canaloplasty requires the use of a 200 μm diameter flexible microcatheter with a blunt atraumatic 250 μm tip (iTrack 250 A, iscience Interventional, Menlo Park, CA). Figure 5 This microcatheter has an internal lumen for injecting OVD. Figure 6 The OVD is injected via a screw driven syringe that allows for precise aliquots to be injected. Figure 7 The microcatheter also has an optical fiber to transmit light and is typically used with the battery powered iLumen Fiberoptic Illuminator (iScience Interventional, Menlo Park, CA) which allows the tip of the microcatheter to glow red or blink to indicate its position within SC during the procedure.
- Canaloplasty can be performed with subconjunctival, sub-Tenon's, or retrobulbar anesthesia.
- A fornix based conjunctival peritomy is performed.
- A superficial scleral flap is created measuring about 5 mm by 5 mm.Figure 8
- A 4 mm by 4 mm deep scleral flap is then created within the borders of the superficial flap dissecting down to within 50 microns of the choroid. Figure 9 This dissection is carried forward into clear cornea. Schwalbe's line is carefully detached. Figure 10 The inner flap is then amputated and a large 500 micron trabeculo-descemetic window is created.
- SC is located and unroofed. A paracentesis is created. The microcatheter is advanced 360° around SC. The optical fiber that illuminates the tip of the microcatheter provides guidance to the path of the catheter as it is advanced. Figure 11
- When the distal tip of the catheter re-emerges at the surgical site, a 9-0 polypropylene (Prolene) suture is tied to it Figure 12 and the microcatheter withdrawn through the canal. Figure 13 Every 2 clock hours a precise aliquot of OVD is injected into SC via the screw driven injector. Care is taken to keep the catheter in perpetual motion through SC when OVD is injected to prevent the creation of a Descemet detachment. The microcatheter pulls the Prolene suture around the canal after it.
- When the microcatheter has completely cleared the canal, the Prolene suture is detached from the catheter. The suture is then and tightened to apply a long-term, moderate tension to the tissues of the inner wall of Schlemm’s canal. Figure 14 Some surgeons may elect to secure a spacer graft in the space within the scleral flap as is done in deep sclerectomy to allow an intra-scleral lake of aqueous to form.
- The scleral flap is then tightly closed with 10-0 nylon suture if a bleb formation is not desired. Alternatively, the flap can be left loose to allow gentle subconjunctival filtration as in deep sclerectomy.
- The conjunctiva is then closed.
Antibiotics are typically given for one week and topical corticosteroids are used and tapered over 4 weeks. At one month postoperatively, if the IOP is not at target a YAG laser goniopuncture or bleb needling can be performed to convert the procedure into a full thickness filtration surgery.
Lewis and colleagues reported the 3 year results of a multicenter trial of 157 eyes that received canaloplasty. Preop IOP was 23.8 +/- 5 on 1.8 +/- 0.9 medications. The overall postoperative IOP at 3 years was 15.2 +/- 3.5 on 0.8 +/- 0.9 medications, representing a 36.1% reduction in IOP. There was a subset of 36 eyes that received cataract surgery concomitantly with canaloplasty had significantly better results with an IOP of 13.6 +/- 3.6 (a 42% reduction) on 0.3 +/- 0.5 medications. 
Canaloplasty is thought to be safer than trabeculectomy but it is also generally considered to be inferior in terms of efficacy in IOP lowering. Tam and colleauges challenged this notion, showing that in certain circmstances canaloplasty can perform quite comparably to trabeculectomy. In their retrospective comparison of 101 eyes, 50 receiving canaloplasty and 51 receiving trabeculectomy they reported equal result in IOP and medication use. The canaloplasty cohort went from preop IOP 26.4 +/- 6.5 on 3.6 +/- 0.9 medications to postop IOP 13.4 +/- 2.7 on 0.6 +/- 1.1 medications. The trabeculectomy cohort went from preop IOP 26.8 +/- 8.1 on 3.6 +/- 1.1 medications to postop IOP 12.3 +/- 3.5 on 0.7 +/- 1.3 medications. 
If the deep scleral flap is dissected too deep the trabeculo-descemetic window can be perforated. Figure 15 If this occurs a sclerotomy can be created with an iridectomy and the procedure can be converted to a trabeculectomy.
Lewis' study reported only 16 adverse events in 12 eyes. Mild hyphema is common and was seen in 10.2% of eyes and all except in 3 eyes were resolved by 1 month. Figure 16 A Descemet detachment with intrastromal corneal blood was seen in 3.2% of eyes. Figure 17 3 eyes had persistent IOP elevated > 30 within the first 90 days. 2 were converted to trabeculectomies and 1 underwent YAG goniopucture. Figure 18A and Figure 18B 7 eyes had increased IOP in the late postoperative course of which 5 required procedures including goniopuncture, iridoplasty, cyclophotocoagulation, and a trabeculectomy. There was only a 0.6% rate of early hypotony but there were no flat anterior chamber, choroidal detachment, or endophthalmitis reported.
- American Academy of Ophthalmology. Glaucoma: Angle based surgery: Ab interno trabeculotomy (Trabectome), canaloplasty, trabecular micro-bypass (iStent) Practicing Ophthalmologists Learning System, 2017 - 2019 San Francisco: American Academy of Ophthalmology, 2017.
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- Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: Three year results of circumferential viscodilation and tensioning of Schlemm’s canal using a microcatheter to treat of open-angle glaucoma J Cataract Refract Surg. 2011;37:682-690.
- Tam DY, Calafati J, Ahmed I. Non-penetrating Schlemm’s Canaloplasty vs Trabeculectomy. Presented at the American Glaucoma Society meeting, Naples, FL, March, 2010.