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Glaucoma surgery is intended to reduce intraocular pressure (IOP) when the target IOP cannot be reached with medications. Due to complications with established surgical approaches (e.g., trabeculectomy), alternative surgical treatments, including transluminal dilation by viscocanalostomy or canaloplasty, are being evaluated for patients with glaucoma.
Trabeculectomy is the most established surgical procedure for glaucoma, allowing aqueous humor to directly enter the subconjunctival space. This procedure creates a subconjunctival reservoir with a filtering “bleb” on the eye, which can effectively reduce IOP, but is associated with numerous and sometimes sight-threatening complications (e.g., leaks, hypotony, choroidal effusions and hemorrhages, hyphemas or bleb-related endophthalmitis) and long-term failure.
Alternative nonpenetrating methods are being evaluated to treat glaucoma are viscocanalostomy and canaloplasty. Viscocanalostomy is a variant of deep sclerectomy and unroofs and dilates the Schlemm canal without penetrating the trabecular meshwork or anterior chamber. A high-viscosity viscoelastic solution (e.g., sodium hyaluronate) is used to open the canal and create a passage from the canal to a scleral reservoir. It has been proposed that viscocanalostomy may lower IOP while avoiding bleb-related complications.
Canaloplasty, which evolved from viscocanalostomy, involves dilation and tension of the Schlemm canal with a suture loop between the inner wall of the canal and the trabecular meshwork. This ab externo procedure uses the iTrack illuminated microcatheter to access and dilate the length of the Schlemm canal and to pass the suture loop through the canal. An important difference between viscocanalostomy and canaloplasty is that canaloplasty attempts to open the entire length of the Schlemm canal, rather than one section of it.
In 2004, iTrack™ was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process as a surgical ophthalmic microcannula that is indicated for the general purpose of “fluid infusion and aspiration, as well as illumination, during surgery.” In 2008, iTrack™ was cleared by FDA for “catheterization and viscodilation of [the] Schlemm canal to reduce intraocular pressure in adult patients with open angle glaucoma.”
I. Canaloplasty may be considered MEDICALLY NECESSARY AND APPROPRIATE as a method to reduce intraocular pressure (IOP) in patients with chronic primary open-angle glaucoma under the following conditions:
II. Canaloplasty is considered EXPERIMENTAL/INVESTIGATIVE for all other indications, including angle-closure glaucoma, due to lack of clinical evidence demonstrating an impact on improved health outcomes.
III. Viscocanalostomy is considered EXPERIMENTAL/INVESTIGATIVE under all indications, including angle-closure glaucoma, due to lack of clinical evidence demonstrating an impact on improved health outcomes.
Link to Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2021-12/BCBSMN-Pre-Auth-Request-fillable-X18509R07.pdf
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