
Several new technologies that promise to make eye surgery safer and better were on display at the annual meeting of the American Society of Cataract and Refractive Surgeons in New Orleans. If you didn't make it down to the Big Easy in May, here are a few of the highlights you missed.

Avedro | Corneal cross-linking
The FDA recently approved this game-changing treatment for progressive keratoconus, a disease in which the normally round cornea thins and begins to bulge into a cone-like shape. Here's how it works: You debride the corneal epithelium before applying a 30-minute soak with a riboflavin formulation. After the soak, you use the company's KXL System to apply ultraviolet light to the eye for 30 minutes. Riboflavin, plus UV light, plus oxygen creates a chemical reaction that helps generate collagen fibers in the cornea. Those fibers create crosslinks that stiffen the corneal tissue to prevent keratoconus from getting worse.
Avedro has started shipping the KXL System to facilities and has begun manufacturing the riboflavin formulations, which will be available in the fall. A starter package costs about $86,000, which includes the KXL System and riboflavin treatments for 20 eyes (10 patients). Ongoing purchases of the riboflavin formulations will cost an average of $500 per eye.

Ellex Medical | Ultra Q Reflex YAG laser
To see and treat floaters in the posterior vitreous, the YAG's laser has to be coaxial with the viewing optics. Ellex came up with an ingenious design that makes coaxial illumination possible, allowing the laser beam to focus on the posterior vitreous. You can use this laser to safely treat floaters in the posterior vitreous as long as you follow treatment guidelines and select the right patients (pseudophakic individuals, for example). The procedure has resulted in a 70% reduction in floaters with a single treatment and up to a 90% reduction with 2 treatments.
Surgeons and eye centers have to decide if eliminating floaters is a medically necessary vitreolysis treatment (floaters caused by cataract surgery, for example) for which they're reimbursed about $300 or a cosmetic fix that patients would pay significantly more for. It's a gray area, but also an exciting revenue opportunity for eye surgery centers, which all need a YAG laser. Why not invest $45,000 for one with this capability and pay for it by performing standard YAG capsulotomy or figure out how to incorporate the premium cosmetic floater reduction treatment into the mix?

Mynosys | Zepto Precision Pulse Capsulotomy
Here's a slick and promising new way to create a capsulorhexis. Surgeons center the device over the visual axis and activate the tip, which sucks to the capsular bag to trap and heat surface water molecules in 4 milliseconds. The molecules rapidly expand to cleave tissue. A company rep says the strength of the resulting cut's edge is 2 to 4 times greater than a laser-generated capsulorhexis. The platform's power supply unit costs $2,000. The single-use handpiece, which can be inserted through incisions as small as 2.2 mm, costs $110. Mynosys expects to receive 510(k) clearance for the system later this year.
The only other practical methods for making a capsulorhexis are manual techniques, which require a great deal of skill, and the femtosecond laser, which requires a $500,000 initial investment, per-click fees and maintenance contracts. There's no evidence that making a capsulorhexis with a laser improves clinical outcomes, so it makes sense to consider a more affordable option. This device could level the surgical playing field, allowing low-volume surgeons to make the near-perfect capsulorhexis needed to implant specialty lenses and achieve the enhanced refractive outcomes for which patients pay a premium.

Surgilum | RoboMarker
This self-leveling cornea marker features a hidden weight system that maintains the axis surgeons dial up, allowing them to focus on marking the cornea rather than keeping the device level. Its sterile disposable tips are pre-inked with a dry formula, meaning the marks go on as clean lines rather than smeared blobs, and remain visible for up to 2 hours. Surgeons can therefore mark the cornea in pre-op instead of in the OR.
Before refractive and cataract surgeries, I mark the cornea at 3 and 9 o'clock when the patient is sitting up. Once the patient is in the OR, I need to find those marks and adjust them slightly to, say, 2 and 8 o'clock when the patient lies back and cyclotorsion — the slight rotation of the eye around its axis — occurs. Being able to dial up 2 and 8 o'clock on the RoboMarker and mark the cornea once in pre-op instead of making adjustments in the OR could be a significant time-saver. The marker handle costs roughly $1,700 and the disposable pre-inked tips run $10 per case. Tips that mark with ink visible under the infrared glare of the femtosecond laser are also available.

Surgilum | Photon Speculum
Some of the best ideas are so simple they make you wonder, Why didn't I think of that? I had one of those moments when I saw this ingenious device. Surgeons can turn off the surgical microscope's illumination and power up the LED lights on this single-use speculum to dramatically improve visualization of anatomical detail during procedures that require angled approaches to the eye. For example, surgeons who perform LASIK surgery typically must move patients to the slit lamp to check for fibers. This device eliminates that time-consuming step; surgeons simply use it at the point of care in the procedure room. The speculum costs about $370, but a company rep says the per-case cost should eventually decrease to about $50. You need to compare that expense to the cost of using a slit lamp and the OR minutes wasted as you move the patient back and forth for the exam. Perhaps you can keep one of these devices on hand in its sterile packaging and, if there are any concerns about a case outcome, open it up to have a look.

Arcscan | Insight 100
Surgeons use this pre-op ultrasound scan to view a cross-section of the cornea. During the scan, patients sit upright, lean forward into a soft membrane seal and focus on a fixation target, so the results are based on a close-to-natural-eyesight condition of the capsule and surrounding anatomy. Optical coherence tomography (OCT) exams aren't quite as clear and predictable. Unlike OCT exams, this scan provides views to the capsule bottom, meaning surgeons can measure the volume of the total capsular bag and focus on the zonules to see how both might impact placement of the intraocular lens implant.
Although this scan was originally developed for keratoconus screening, I'm intrigued by its potential application for cataract surgery. Surgeons don't know for sure where a lens implant will ultimately sit in the capsular bag, which is unique in every patient. They make incredibly accurate guesses, but zonules and muscles can alter the final position of the lens, and any slight change can impact the post-op accuracy of refraction. Consider that 83% of my patients are within a half diopter of where the lens is supposed to sit. But am I ever going to get to 90% accuracy? Surgeons could theoretically use this scan to predetermine the final position of the implant and adjust the power of the lens to optimize refractive outcomes. The scanning platform costs about $79,000 and you'll pay $50 per scan for the single-use membrane seal.

Imprimis Pharmaceuticals | MKO Melt
Imprimis is on a mission to save health care billions of dollars by marketing low-cost therapeutics that have the same essential efficacy as much more expensive products. Sure the company makes money, but it's not trying to gouge physicians and patients. I respect that.
At this year's show, Imprimis introduced MKO Melt, a sublingual IV-free sedation alternative. Patients place 1 to 2 of the small tablets under the tongue, where the midazolam, ketamine and ondansetron compound (the MKO in the product's name) dissolves into the bloodstream in a matter of minutes. A company rep says Melt's sedative effect is more consistent than IV sedation and leaves the bloodstream in a couple hours, which helps speed recoveries and improve OR efficiencies. The rep also says several eye facilities have used Melt to go IV-free and say it has made the patient experience much more enjoyable. There's definitely a market for this form of sedation in cataract surgery, even for facilities that can't or don't want to eliminate IVs altogether. There are always patients in whom starting a line is difficult, if not impossible — elderly cancer patients, for example. For those patients, the anesthesia provider might titrate Xanax or sublingual Versed to an effective dose. Using Melt in those instances would provide a more consistent dose and predictable results. I think keeping a stock of these tablets on the shelf in case you can't start an IV would be useful. Imprimis says Melt costs $25 for a 2-Trokie dose, which is the most you'd need to sedate a patient.

Leica | Proveo 8 surgical microscope
Leica's new surgical microscope offers 4 optical pathways, so the physician doesn't need to share light with his assistant, who also enjoys a full stereo view of the action. The light source is coax 4 illumination; 4 LED lights provide consistent red reflex throughout the whole case. The red reflux remains strong because the light is entering the eye at various angles. That's a valuable feature when the phaco tip is in the eye, tilting and moving in different directions.
The scope's fusion optics make that enhanced visualization possible. One aperture is smaller to provide better depth of field and one is larger to provide optimal resolution. Your brain fuses the images, so you don't realize the difference between the 2 apertures as you're looking through the scope. In addition to providing clearer views of the eye anatomy for safer surgery, this innovation could eliminate the need to constantly adjust the optics after setting the correct focus at the beginning of the case.
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For the Discriminating Eye Doc
- Less waste, lower cost. The Revolver Laser Probe System from Katalyst Surgical promises to cut your femtosecond laser case costs in half. It's made up of 3 components: the handpiece, a universal connector that attaches to the laser unit and a single-use laser fiber — the only part of the system that's disposed of after each case. The handpiece comes in a variety of tip styles and is made of titanium and high-quality stainless steel, which provide surgeons with a better feel than fully disposable options. It's compatible with all femto units on the market. The 3 components cost $280. After that initial investment, the single-use laser fiber runs $70 per case, much less than the $150 you'd pay for fully disposable probes.
- 2-in-1 laser. Give your center and surgeons some versatility with Ziemer's Z8 Femto, a mobile femtosecond laser platform for performing cataract surgery and LASIK procedures. The platform, which received FDA clearance last October, uses lower energy than other femto lasers on the market, making it gentler on the eye. The unit's flexible arm and mobility let you bring the laser to the patient, meaning surgeons can perform the laser and manual portions of cataract surgery in the same location.
- Live refractive monitoring. The Holos IntraOp System from Clarity Medical Systems uses proprietary wavelength technology to measure real-time refraction of the eye and to provide the surgeon with spherical power, level of astigmatism and axis of astigmatism. The system sends live refraction through a built-in algorithm to generate a recommended power for the lens implant and expected outcome in diopters off the zero-target, which would be a perfect refractive outcome. The system is currently available for Zeiss surgical microscopes, but the company says it has plans to partner with other major scope manufacturers.
- Ultrasound with light. The NIR 900 surgical microscope from Haag-Streit now features iOCT Imaging, which provides infrared scans of the eye's anterior and posterior segments at a depth of 4.2 mm. The scan's signal appears as an overlay on the microscope's video display and provides incredible detail of small tissue, which is particularly valuable for corneal surgeons performing DSEK or DMEC cases.





Diamatrix | XpandNT Iris Speculum
This pupillary expansion device gently expands the eye through 8 points of fixation to create 6.7 mm of dilation through a 2.4 mm incision for improved and safer access to the anterior segment. The ring has a very low profile compared with similar devices on the market, which provides surgeons with plenty of maneuverability within the eye.
The XpandNT is now available in both reusable and single-use versions, so it's clear that Diamatrix is gearing the product to be financially accessible to large hospital systems and small independent ASCs. That's nice to see. Hospitals, which get paid 40% more than my free-standing ASC does for cataract surgery, might not think twice about paying $100 for the disposable device or may want to invest $250 in the reusable ring, which is validated for 5 uses. A high-volume surgery center might not have the time or staff to properly care for and reprocess the delicate reusable ring in order to achieve value for the higher cost. In addition, hospitals and surgery centers that exclusively use single-use supplies may not want to introduce a reusable device to the mix. Whatever the case, Diamatrix has given surgeons and facility leaders an option. OSM