At Press Time
Laser Cataract Surgery on the Rise
Survey quantifies femto adoption and premium IOL implantation.
By René Luthe, Senior Associate Editor
■ Medical device consulting company SM2 Strategic has released its 2013 laser Cataract Surgery Survey, dedicated to femtosecond-based cataract surgery, its use and how it’s being brought to market across the United States. The survey includes data from 205 cataract surgeons at 65 centers and 275,000 cases spanning slightly more than two years.
On average, respondents used a femtosecond laser in cataract surgery for 12 months. They performed an average of 660 procedures a year, or more than 50 a month. Here are some highlights:
► Two thirds of laser cataract procedures in the first quarter this year involved premium IOLs.
► 30% of all cataract procedures included femtosecond.
► Penetration of premium IOLs remained steady. Toric IOLs were used in 8.8% of all cataract procedures in 2011, 8.6% in 2012 and 8.5% in Q1 2013. Presbyopia-correcting IOLs accounted for 12.9% in 2011 and 2012, and 13.6% in Q1 2013.
► 46% said the adoption of femtosecond increased their premium IOL procedures; 45% said it made no different; and 9% said such premium IOL procedures decreased.
► 44% said adoption of the laser increased overall procedure volumes, 53% reported no change and 3% reported a decrease.
► When asked how they are charging for laser cataract surgery, refractive package fee schedules reflected a weighted average up-charge of $859 over conventional cataract surgery. The up-charges were smaller, however, when premium IOLs were used: $664 for toric IOLs,; $673 for multifocal IOLs; and $1,058 for conventional IOLs.
Economics of Femto-Phaco |
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• $603,400 - 5-year total average cost of laser. • $438,200 - 5-year cost of laser alone. • $165,000 - 5-year cost of service. • 19 - laser cataract cases a month to break even. • 227 - laser cataract cases over 5 years to break even. • 71% - centers at break-even or better. • 59% - single-surgeon centers near break-even or better. • 95% - multi-surgeon centers at break-even or better. |
“It’s important that we describe this as a weighted average, because we saw many centers that did not increase their fees in their second and third levels of refractive packages,” a spokesman at SM2 said.
The survey was sponsored by Alcon (Fort Worth, Texas), Bausch + Lomb (Rochester, NY), Lensar (Winter Park, Fla.) and OptiMedica (Santa Clara, Calif.). To see the complete findings, go to www.sm2strategic.com/lcs2013results.
In the News … |
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■ AMO’s Tecnis Toric wins approval. Abbott Medical Optics said the Tecnis Toric 1-Piece IOL has received FDA approval and will be launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism. “The Tecnis Toric IOL decreases astigmatism while improving visual quality with improved functional vision,” said Kevin Waltz, OD, MD, Eye Surgeons of Indiana, and clinical investigator for the Tecnis Toric IOL. “Having implanted several Tecnis Toric IOLs within clinical trials, I find it delivers excellent patient results.” ■ Alcon glaucoma drug is approved. Alcon Laboratories said the FDA has approved Simbrinza Suspension, an IOP-lowering drug indicated for patients with primary open-angle glaucoma or ocular hypertension. Simbrinza is a fixed-dose combination medication that Alcon says offers a wide range of treatment possibilities due to its strong efficacy and ability to lower elevated IOP by 21% to 35%. In addition, Alcon says Simbrinza is the only available fixed-dose combination therapy for glaucoma in the United States without a beta-blocker. Simbrinza suspension is a fixed-dose combination of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha-2 adrenergic receptor agonist (brimonidine tartrate 0.2%). It combines the two drugs into one multidose bottle, which is designed to reduce the medication burden for glaucoma patients. Dosing is one drop of Simbrinza into the affected eye(s), three times per day. |
Promising Results From Iontophoresis Study
EyeGate drug delivery method treats anterior uveitis.
■ EyeGate Pharma said topline results from its phase 3 study of the corticosteroid formulation EGP-437 demonstrated that two iontophoretic treatments of the agent achieved the same response rate as prednisolone acetate 1% administered as multiple daily eyedrops in patients with anterior uveitis. Iontophoresis is the delivery of drugs through the skin by means of a small electric charge. It is sometimes called an injection without a needle.
In this randomized, double-masked placebo-controlled study conducted at 45 clinical sites around the United States, a total of 193 patients were randomly assigned into one of two treatment arms — iontophoretic treatment on days 0 and 7 or 14 days, or daily treatment of prednisolone acetate 1% ophthalmic solution, the current standard of care. Two weeks of standard tapering followed the treatments. The primary efficacy endpoint was the proportion of patients with anterior chamber cell count of zero on day 14, which is defined as a complete response.
Eliminates Compliance Issues
In all randomized subjects, EyeGate reported that only two iontophoretic treatments with EGP-437 (days 0 and 7) resulted in 32 complete responses out of 96 patients on Day 14. The standard-of-care uveitis treatment also yielded 32 complete responses out of 97 patients who received multiple daily self-administered eye drops over the first 14 days.
Regarding safety, the company said the incidence and severity of treatment-emergent adverse events in both groups were comparable. The the EGP-437 group reported fewer incidences of elevated IOP.
“Inadequate compliance with aggressive eyedrop regimens often leads to treatment failures” commented John Sheppard, MD, the study’s principal investigator. “Offering our uveitis patients a safe, effective treatment option controlled by the health-care provider rather than the patient represents an important breakthrough, especially when we see a history of poor compliance, difficulty with eye drop self-administration, elevated IOP, glaucoma, or preservative toxicity.”
A Controlled Treatment
“This is a major milestone for the ophthalmic community as it further validates a unique new way to deliver therapeutics into the eye,” said Stephen From, president and CEO of EyeGate Pharma. “Treating uveitis requires up to 16 eyedrops per day over a period of four to six weeks, which is very inconvenient for the patient. A couple of treatments with our product produced the same results, which is much simpler and more reliable for the patient.”
In the News … |
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■ FDA panel recommends breakthrough B + L lens. The FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee has voted 10-1 to recommend approval of Bausch + Lomb’s Trulign Toric accommodating posterior chamber IOL, the first accommodative toric IOL to receive such a recommendation. The panel’s vote was based on clinical trial data that the panel considered sufficient evidence to demonstrate that the Trulign Toric is safe and effective. The panel’s vote is only a recommendation and the FDA has to make a final decision on whether to approve the lens. However, panel votes do carry weight with the FDA. ■ Eye bank pre-loads tissue for cornea transplants. Lions Eye Institute for Transplant & Research (LEITR) said that for the first time, EndoGlide (Angiotech Pharmaceuticals Inc.) cartridges pre-loaded by an eye bank have been successfully used in corneal transplantation. The EndoGlide was selected for initial endothelial keratoplasty transplant procedures utilizing donor endothelial tissue that was pre-cut, trephined and preloaded into the device at LEITR in Tampa, Fla. It was then transported to the Massachusetts Eye and Ear Infirmary, where the initial procedures were performed by Roberto Pineda II, MD, associate professor of Ophthalmology at Harvard Medical School. “In published literature, the EndoGlide device has already shown excellent outcomes in endothelial cell protection when loaded by surgeons,” says Dr. Pineda. “Tissue preparation and device pre-loading by eye banks simplifies the surgery and may provide increased reproducible outcomes for endothelial keratoplasty.” |
Ophthalmologists Are Low on Burnout Scale
But 30% report signs of dissatisfaction.
■ When asked, most ophthalmologists will say they enjoy their career. They will often cite the fact that they have the ability to greatly improve the vision and quality of life for many of their patients, usually in a short time. Seeing these positive outcomes tends to give ophthalmologists a deep sense of satisfaction.
The results of the 2013 Medscape Physician Lifestyle Report largely bear out a generally positive view ophthalmologists have of their profession. However, despite the profession ranking 22nd out of 24 medical specialties on the burnout scale, about 35% of ophthalmologists surveyed say they have lost their zest for their work, feel cynical, or suffer from a low sense of personal accomplishment — all classic signs of burnout.
Distress in Other Specialties
Though a 35% dissatisfaction rate may seem high, more than half of all emergency medicine physicians and half of all critical care specialists report signs of work-related distress.
In dermatology, a specialty not known for encountering high-pressure clinical situations, a higher degree of burnout was reported than in ophthalmology. The stress level in ophthalmology compares to that of rheumatologists, pediatricians and psychiatrists. Only pathologists show fewer signs of burnout, the data suggest.
Ophthalmologists also ranked at the bottom of the list for burnout severity, with a mean score of 3.4 on a scale of 1 (“does not interfere with my life”) to 7 (“so severe that I’m thinking of leaving medicine altogether”).
Ophthalmologists Do Complain
But like their colleagues in other disciplines, ophthalmologists dislike having to do too many bureaucratic tasks, coping with government regulation, not getting paid enough, spending too much time at work, computerizing their practices, feeling like just “another cog in a wheel,” and dealing with too many difficult patients. Ophthalmologists also complain, although to a lesser degree than other specialists, of an inability to provide patients with the quality of care they need, troublesome staff or colleagues, compassion fatigue, and coping with difficult employees.
Middle-aged practitioners (ages 46 to 55) were more likely to report burnout than other age groups.
For relief from stress, most ophthalmologists opt for spending time with family, physical activity, reading, travel, and good food and wine.
In terms of self-perceptions of health, burned-out ophthalmologists were slightly less positive about their own health. Overall, they reported less confidence about their health than their content colleagues.
Alcohol use or abuse does not seem to be an issue with ophthalmologists, with 25% of burned-out and 26% of content ophthalmologists reporting being non-drinkers, and 56% and 53%, respectively, reporting that they have fewer than one drink a day.
B + L Offers Femto-phaco Instruments
The 13-product set was designed specially for laser cataract surgery.
■ Bausch + Lomb Storz is introducing a femtosecond cataract instrument set designed specifically to be used with femtosecond laser platforms. Developed in collaboration with leading femtosecond laser surgeons, the 13-product set includes choppers, cannulas, forceps, spreaders, dissectors and a polisher.
“These instruments are designed to help optimize the benefits of the precision and accuracy of the femtosecond laser and facilitate rapid removal of the lens,” says Sheraz M. Daya. MD, FACS, medical director at the Center for Sight in London, and designer of the Daya Femto Trans-Lens Hydro Cannula, which is part of the set.
Design of all the instruments in the set was inspired by observations made by the surgeons during their femto cataract procedures and pursued through close interaction with the instrument design team at Bausch + Lomb Storz.
Specially designed femto-phaco instruments have been introduced by B + L Storz.
“The use of the femtosecond laser and the manner in which it performs a capsulotomy means conventional methods of lens removal might benefit from modification. The engineers at Bausch + Lomb Storz were very receptive to the idea of an instrument that would facilitate and change conventional surgery,” says Dr. Daya. “I sent videos of my technique and we discussed instrument shape and dimensions. Following an iterative process with several different cannulas, we came up with an optimal gauge size and cannula dimension that accomplished the goal satisfactorily. I am pleased to see the final product now available commercially.”
The 13 new femtosecond cataract instruments are available in the United States and will soon be introduced in international markets. All instruments with the exception of the CapsuleGuard I/A Handpiece are reusable. They can be ordered individually or as a set. Information on the complete range of Bausch + Lomb Storz new femto-phaco instruments is now available at www.StorzEye.com
In the News … |
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■ BVI buys Odyssey product lines. Beaver-Visitec International Inc. (BVI) has purchased the ophthalmic assets from Odyssey Medical Inc. Odyssey is best known in the ophthalmic community for its Parasol brand of punctal occluders and its focus on combating dry eye. “We are excited to bring Odyssey to our customers as a part of the Beaver-Visitec International family. Odyssey is a perfect fit with our goal to continually expand our offerings with products that meet or exceed our customers’ standards,” said Tom Kapfer, CEO of BVI. “Odyssey’s Parasol brand reflects this belief and is the most trusted and recognized brand of punctal occluders.” ■ Lensar femto-phaco gets new approval. Lensar Inc., developer of the Lensar Laser System for refractive cataract surgery, said its laser system has received 510(k) clearance from the FDA for the execution of arcuate incisions during cataract surgery. With this latest regulatory milestone, the Lensar System is now cleared to perform both corneal and arcuate incisions, as well as lens fragmentation and anterior capsulotomy (with or without phacofragmentation), during cataract surgery. The Lensar Laser System is currently available for sale to cataract surgeons in the United States, Europe and several other countries around the world. ■ Sony announces imaging installations. Sony Electronics has completed its the first east and west installations of its end-to-end 3D imaging solution for ophthalmic surgery. Robert Cionni, MD, of the Eye Institute of Utah, Salt Lake City, and Richard J. Mackool, MD, of the Mackool Eye Institute and Laser Center, are the first to install this complete medical-grade 3D imaging solution, which includes Sony’s MCC-3000MT 3D camera, HVO-3000MT 3D video recorder, and 3D display, the LMD-2451MT 24-inch LCD widescreen monitor with full HD resolution. OM |