The Results of Our Last Question
Some people consider corporate consolidation to be detrimental to the customer due to decreased competition and fewer products from which to choose. On the flip side, others argue that consolidation generates financial interest in a market, which leads to an increase in innovative start-up companies and long-term technological advances for the ophthalmic field. How do you view corporate consolidation within the ophthalmic market?
A. Positive effect: 25%
B. Negative effect: 67%
C. Will not have an effect: 0%
D. Do not know: 8%
FDA Recalls LASIK Treatment Algorithms
In April 2007, Cataract & Refractive Surgery Today reported that Alcon Refractive Horizons Inc. (Orlando, FL) issued a safety alert for the Ladar6000 excimer laser. Surgeons were directed to discontinue using the laser for myopic CustomCornea procedures (Alcon Laboratories, Inc., Fort Worth, TX) due to reports that the laser was creating central islands in patients' corneas.
This week, the FDA issued a Class 1 recall for the CustomCornea algorithms used by the Ladar6000 laser to correct myopia with (M3) and without (A7) astigmatism.¹ According to the FDA's notice, these algorithms "caused corneal abnormalities ('central islands') … [and] resulted in decreased visual sharpness (visual acuity)." The agency warned that these adverse effects may not be correctable with additional laser-based surgery or with eyeglasses or contact lenses.
At press time, Alcon Laboratories had deactivated the recalled algorithms in all of the Ladar6000 lasers in the US.
Prophylaxis for Endophthalmitis May Have Long-Term Benefits for Medicare
A retrospective analysis of Medicare beneficiaries who underwent cataract surgery between 1997 and 2001 showed that the development of postoperative endophthalmitis significantly increased the total cost of the procedure.
Compared with the unaffected controls, the patients who developed endophthalmitis filed more claims for inpatient care (20% vs 2%), outpatient care (83.5% vs 52.4%), and Part B services ($11,742 vs $5,391). The investigators reported that, overall, "total claims and payments were approximately 2.5 more for [patients with endophthalmitis] than for controls."¹
The researchers suggested that routine prophylaxis for endophthalmitis may provide more benefits than just protecting patients from a potential loss of vision. "With as many as 0.1% of patients contracting endophthalmitis after cataract surgery, and Medicare payments almost $3,500 greater for these patients, serious consideration should be given to the potential cost savings to Medicare associated with prophylaxis for endophthalmitis," they concluded.
See the April 2007 issue of Cataract & Refractive Surgery Today to read about the current state of antibiotic prophylaxis.
Study Investigates MMC's Effect on Endothelial Cells
A prospective, interventional, nonrandomized study of 80 eyes of 40 patients suggested that the prophylactic application of mitomycin C (MMC) to the ablated area of the cornea area during LASEK did not negatively affect the postoperative density of corneal endothelial cells.¹
Masked observers evaluated pre- and postoperative specular microscopic photographs of 40 consecutive patients who underwent LASEK either with (n = 48) or without (n = 32) MMC. The patients were assigned to treatment groups according to their targeted depth of ablation (non-MMC, ≤ 50 µm; MMC, ≥ 50 µm.)
The observers noted that the endothelial cells' density in both groups increased by approximately 100 cells/mm² at 3 months postoperatively. Because the investigators did not detect a significant intergroup difference in the density of endothelial cells, (non-MMC, 2,562.5 ±258.7 cells/mm²; MMC, 2,525.0 ±312.5 cells/mm²), they concluded that one "intraoperative application of MMC 0.02% for 30 seconds does not cause a significant change in endothelial cell density."
Update on Recalled Contact Lens Solution
An analysis of Acanthamoeba keratitis infections among contact lens wearers in Illinois and Indiana between 2003 and 2006 suggested that the outbreak was strongly associated with the use of Complete MoisturePlus Multi-Purpose solution (Advanced Medical Optics, Inc., Santa Ana, CA).
The investigators administered surveys and collected water samples from 39 patients diagnosed with Acanthamoeba keratitis and 113 control patients who were identified as contact lens wearers by the University of Illinois at Chicago's Cornea Service. They compiled complete data on the solutions used by 36 of the infected patients, 19 of whom (52.8%) reported they used Complete MoisturePlus exclusively.¹
Although statistical analysis showed that the use of Complete MoisturePlus was an independent risk factor for Acanthamoeba keratitis, the investigators also observed "a positive but statistically weak association … with conditional analysis between three hygiene-related variables (solution reuse, rubbing lenses, and showering with lenses)" that could account for the 38.8% of infected contact lens wearers who did not use AMO's solution.
Jim Mazzo, AMO's President and CEO, told the Orange County Business Journal that the company plans to relaunch a new formulation of Complete MoisturePlus later this year. The new solution will most likely drop its "no rub" designation at that time, he added.²
Company Expands Line of Ophthalmic Sutures
FCI Ophthalmics, Inc. (Marshfield Hills, MA), has added 9–0 polypropylene nonabsorbable sutures to its inventory of ophthalmic devices. According to a news release from the company, the sutures are available in boxes of 12 or individually with the purchase of a Morcher Cionni Capsular Tension Ring (Morcher GmbH; distributed in the US by FCI Ophthalmics, Inc.) They feature two different configurations of needles. For more information, contact FCI Ophthalmics, Inc., at (800) 932-4202.
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