If it ain’t broke, don’t fix it is a motto unimaginative cataract surgeons use to justify their inability to think outside the oculars about improving a procedure that has remained largely unchanged. However, exciting developments in device design and drug delivery could compel eye physicians to at least take a second look at cataract surgery’s clinical routines.

1 Reduced phaco energy

IanTech’s miLoop was introduced in 2017 with the aim of eliminating, or at least significantly reducing, the need for phacoemulsification energy to fragment cataracts before removal. Surgeons insert the pen-like miLoop through a 1.5 mm corneal incision, slide the device’s filament loop in the open position around the cataract’s nucleus and activate the device’s finger lever to halve the nucleus. Surgeons can remove the fragments of soft lenses with only aspiration, but often employ low levels of phaco energy to chop up the fragmented remains of denser cataracts.

Ophthalmic surgeon William Trattler, MD, uses the miLoop in only about 4% of his cases, but appreciates having it nearby to fragment very dense cataracts before dialing back the phaco energy to finish the job. “Less energy translates into lower risk of corneal edema and less inflammation in the anterior chamber,” points out Dr. Trattler, who operates at the Center for Excellence in Eye Care in Miami, Fla.

Despite its slick design and proven clinical performance, the miLoop has yet to gain widespread acceptance among cataract surgeons who don’t see the need to alter the fundamentals of a safe and effective procedure. Cost of the single-use miLoop — about $130 per case — is also a legitimate concern in a specialty with razor-thin profit margins, according to Dr. Trattler. He admits surgeons in larger multi-specialty facilities might be more inclined to use the device than budget-conscious physician-owners of eye-only centers who case cost down to the penny.

Still, he believes the miLoop deserves a spot on a cataract surgeon’s preference card. “They can reach for it when it will make a clear clinical difference during advanced cases,” he says. “When I need it, I’m very happy to have it in my toolbox.”

2 Injectable drugs

There are several new and promising therapies available to treat post-op inflammation in the eye and ocular pain following cataract surgery:

• Dexycu (dexamethasone intraocular suspension) from EyePoint Pharmaceuticals is a well-trusted and potent single-dose, sustained-release steroid, says John Hovanesian, MD, of Harvard Eye Associates in Laguna Hills, Calif. Surgeons administer a 5-micron dose into the ciliary sulcus at the end of surgery, after they’ve implanted the IOL and removed the viscoelastic, he says. After injection, Dexycu transitions into a white liquid sphere in the anterior chamber and slowly dissolves to deliver a steady-state dose of the steroid inside the eye for a month.

“It’s FDA approved and has an acceptable safety profile, meaning it doesn’t increase risk of intraocular pressure spikes more than topical dexamethasone,” says Dr. Hovanesian.

Last month, CMS assigned a J-code for Dexycu, J1095, which takes effect Jan. 1, and will replace the previously issued C-code for Dexycu (C9034). For around 3 years, Dexycu will have transitional pass-through status from CMS, says the company.

• Dextenza from Ocular Therapeutix is a preservative-free corticosteroid intracanalicular insert that Dr. Hovanesian says should gain FDA approval in the first quarter of 2019. The punctal depot, which is made of hydrogel, is placed through the punctum in the lower eyelid at the end of surgery. The gel swells as it absorbs water and remains firmly in place as it slowly dissolves to deliver dexamethasone to the eye’s ocular surface for 30 days. Dr. Hovanesian says it’s easy to remove the depot if the patient experiences any adverse events.

“Dextenza has a retention rate of about 95%, which is far better than a patient’s typical compliance with a post-op drop regimen,” he adds.

• Inveltys from Kala Pharmaceuticals is a loteprednol etabonate ophthalmic suspension topical corticosteroid comprised of mucus-penetrating particles, which promotes rapid delivery of the medication into the eye. That rapid delivery, says Dr. Hovanesian, means Inveltys provides the benefit of a potent steroid without such side effects as intraocular pressure spikes.

The drug is indicated for twice-a-day treatment after surgery, instead of the standard 4 times daily regimen. That’s a significant advantage, says Dr. Hovanesian, who points out that a majority of cataract patients must self-administer a topical antibiotic, steroid and nonsteroidal to prevent infection and treat post-op inflammation and pain.

“Patients often complain about the complex post-op drop regimen they must endure,” he adds. “They feel like their eye is healed days after surgery and wonder why they have to continue self-administering drops for several weeks. Any product that reduces the frequency of drops or simplifies the post-op drop regimen will make the cataract surgery experience better for patients.”

• Omidria from Omeros is a phenylephrine and ketorolac intraocular irrigating solution that's administered through balanced saline solution during surgery and indicated to maintain pupil dilation and improve post-op healing.

“The drug has been proven to reduce the risk of the most feared complications of cataract surgery by preventing intraoperative miosis,” says Dr. Hovanesian.

Omidria faced an uncertain future when its “pass-through” status expired on Dec. 31, 2017. CMS grants pass-through status to test the effectiveness and demand of innovative drugs and products. In Omidria’s case, surgery centers could bill CMS separately for nearly $500 ($465 per 4 ml vial, the drug’s average sales price, plus 6%) to cover the drug’s per-case expense. When the pass-through status went away, Omidria suddenly became cost-prohibitive.

On Oct. 1, however, CMS reinstated Omidria’s pass-through status and extended it through Oct. 1, 2020. Dr. Hovanesian is encouraged that Omidria is once again widely accessible.

“Cataract surgeons need to work with innovative products,” he says. “For that reason, the pass-through mechanism is essential.”

3 Adding glaucoma surgery

There’s growing interest in combining cataract surgery with ab interno glaucoma techniques, according to Steven Sarkisian, MD, a clinical professor and glaucoma specialist at the Dean McGee Eye Institute in Oklahoma City, Okla. He says there are several minimally invasive glaucoma surgeries that can be used to lower intraocular pressure when clouded lenses are removed:

• Canaloplasty. Surgeons use a microcatheter (the iTrack from Ellex or the Visco 360 from Sight Sciences) to increase outflow of aqueous fluid through viscodilation of Schlemm’s canal and distal collector channels.

• Trabeculotomy. Surgeons can also remove allo or some of the trabecular meshwork, which is the greatest resistance to fluid outflow, with the Trab 360 from Sight Sciences or the Kahook Dual Blade from New World Medical and NeoMedix's Trabectome.

Dr. Sarkisian says clinical evidence and his own experience shows a 360° trabeculotomy is more effective than a partial trabeculotomy. He also prefers to combine cataract surgery with the Trab 360 procedure to effectively remove the entire trabecular meshwork.

“It’s a relatively quick and efficient way of performing a trabeculotomy,” says Dr. Sarkisian.

• In combination. The Omni device from Sight Science lets surgeons perform canaloplasty and trabeculotomy at the same time through a single incision. “You can remove the trabecular meshwork, the greatest resistance to fluid outflow, and also viscodilate Schlemm’s canal, allowing for the opening of collapsed fluid collector channels,” explains Dr. Sarkisian.

There’s no consensus on which method or device is best, according to Dr. Sarkisian. “All appropriate modalities need to be included in the patient care discussion,” he adds.

What is widely accepted is that these methods are safe and effective ways to reduce intraocular pressure and get patients off of burdensome topical glaucoma therapies. Dr. Sarkisian also points out that demand for the procedures will increase as the patient population ages and patients become more aware of the many minimally invasive glaucoma treatment options.

“Case volumes will continue to grow,” says Dr. Sarkisian. “It’s an exciting time to be a glaucoma specialist. More importantly, it’s a much better time to be a patient.” OSM