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News
LASIK Task Force Plans Quality-of-Life Study
A proposed study of patients' quality of life after LASIK will help surgeons to understand more about "the few patients who are dissatisfied" with the procedure, stated one of the study's organizers during a press conference at the 2008 ASCRS Symposium on Cataract, IOL and Refractive Surgery. Steven C. Schallhorn, MD, who chairs the Joint LASIK Study Task Force—the developers of the protocol for the planned study—said that a large patient population will be needed, because few people are dissatisfied with the results of LASIK. The task force is a collaborative effort of the ASCRS, the AAO, the National Eye Institute, and the FDA.
The ASCRS will participate in and cofund the study, said Richard L. Lindstrom, MD, outgoing president of the ASCRS and cochair of the task force. Dr. Lindstrom said the recently formed task force has already accomplished "a great deal." It has (1) completed a global review of the literature, led by cochair Kerry D. Solomon, MD, which found a 95.4% rate of satisfaction with LASIK, (2) requested the assistance of the Department of Defense's Laser Vision Correction Warfighter Program in reviewing the results of LASIK, (3) begun to develop a "validated, robust tool" to assess quality of life after LASIK, and (4) begun to develop the protocol for the planned study.
Although the proposed, large, prospective, multicenter evaluation is still being designed, its fundamentals have been agreed upon, including the objectives of determining (1) the level of satisfaction after LASIK, (2) the change in quality of life after LASIK, and (3) the factors associated with the patients' level of satisfaction, particularly dissatisfaction, Dr. Schallhorn said.
"Our goal is to make this procedure better," he added. "We have done that over the years, and this is another effort to improve the procedure itself."
David Tanzer, MD, the head of the US Navy's laser vision correction program, said at the press conference that he has been invited to present the US military's experience with LASIK at the FDA's Ophthalmic Devices Panel, to be held April 24 to 25 in Gaithersburg, Maryland. (See the June issue of Cataract & Refractive Surgery Today for coverage of the meeting.)
Novartis to Acquire Minority Stake in Alcon. Further Buys Possible
Following an announcement that Novartis International AG (Basel, Switzerland) intends to purchase 74 million shares of Alcon, Inc. (Huenenberg, Switzerland), common stock from Nestlé (Vevey, Switzerland), Novartis Chief Executive Daniel Vasella announced that the company could make more acquisitions in the future.
"One can assume that we will not do an acquisition on this scale and not in this area," Mr. Vasella said in an interview with a Swiss newspaper. "Medium-sized acquisitions É would certainly be possible." No specific acquisitions, however, are planned at the moment, he added.
If approved, the Alcon transaction will give Novartis an approximately 25% minority stake in the company. The deal stipulates that Nestlé will retain approximately 52% of Alcon's outstanding shares and remain the company's majority shareholder. Novartis will have the option to buy Nestlé's remaining shares of Alcon at a fixed price of $181 per share from January 1, 2010, to July 31, 2011. Nestlé will also have the option to sell its remaining stake in Alcon either at that fixed price or a 20.5% premium above the market price of the shares for the preceding week on its option, whichever is lower, according to the announcement.
Additionally, the agreement calls for the expansion of Alcon's board of directors from eight to 10 members, with one additional member chosen by Nestlé and one by Novartis. The agreement is subject to regulatory approvals.
Quality of Life Associated With Presbyopia Measured
Patients experience a nominal decrease in their quality of life when their presbyopia is corrected with glasses, according to a study published in the American Journal of Ophthalmology.1 The change is similar to that of a patient with treated hypertension, the study's authors wrote.
For the cross-sectional analysis based on patients' preferences, investigators interviewed 110 patients with spectacle-corrected presbyopia and a BCVA of 20/40 or better. A utility analysis was used to objectively measure the quality of life associated with the state of health of the patients involved in the study. Patients were asked to consider how valuable they would consider a technology that would improve their vision but would decrease their lifespan.
Among the overall cohort, 11 patients (10%) were willing to trade at least 5% of their remaining lives to be rid of their presbyopia. Six patients (5.5%) were willing to trade a minimum of 10% of their remaining lives to be rid of presbyopia, according to the study.
"In summary, the health state of presbyopia is associated with a mild decrease in quality of life for the average person with the condition," the study's authors wrote. "Higher degrees of presbyopia seem to cause the same quality of life diminution as milder forms."
Still, the researchers wrote, "we suspect from the results of this series that the 10% of presbyopes willing to trade at least 5% of their remaining time of life to be rid of presbyopia may be candidates for an intervention to correct the condition."
Older Corneas Suitable for Transplantation, According to Study
The age pool of corneas for transplantation should be expanded to include donors up to 75 years old , according to a study published in Ophthalmology.1
"The majority of donors have been older, but there has been a great prejudice against using older tissue for fear that it was going to wear out faster," said Dwight Cavanagh, MD, PhD, principal investigator for the study. Because of that fact, many doctors passed on tissue from older donors, he added.
The study examined 1,090 patients undergoing corneal transplantation for a moderate-risk condition (ie, Fuch's dystrophy, pseudophakic corneal edema) and included 5 years of follow-up. Forty-three participating eye banks provided corneas from donors ranging in age from 12 to 75 years, with endothelial cellular densities of 2,300 to 3,300 cells/mm2. The 5-year cumulative probability of graft survival was 86% in both the first donor group (aged 66 years or younger) and second donor group (aged 66 years or older).
Researchers also found that the distributions of the causes of graft failure did not differ between donor age groups.
"The data are very convincing," Dr. Cavanagh said in a press release. "There is not a difference between old and young tissue. What matters is how many cells are alive in the tissue regardless of the age of the donor. And there are plenty of people of older age who have high cell counts," he said.
New Tecnis IOL Outperforms Three-Piece Lens
The clinical performance of the Tecnis 1-Piece (Advanced Medical Optics, Inc., Santa Ana, CA) launched in the US at the 2008 ASCRS Meeting, is at least as good as, if not better than, its three-piece predecessor, according to Ulrich Mester, MD, of the Augenklinik der Bundesknappschaft Sulzbach, in Germany.1
In a prospective study of 21 patients, Dr. Mester implanted a Tecnis 1-Piece IOL to study the stability of the lens' position, patients' postoperative spherical aberration and contrast sensitivity, and the IOL's clinical performance. Dr. Mester said that almost no spherical aberration was present and that young, phakic eyes had similar results compared with young, sound eyes. The haptic offset and three-point fixation decreased the incidence of decentration and tilt.
At 3 months, UCVA, BCVA, and contrast sensitivity were reportedly comparable to results previously published for the Tecnis three-piece IOL.
Anesthetics Compared in Cataract Surgery
Topical anesthesia with levobupivacaine (0.75%) and ropivacaine (1%) were safe and more effective than lidocaine (2%) in cataract surgery, according to a study published in Eye.1
The comparative clinical trial examined 105 patients scheduled for a cataract surgery where one of the three anesthetics was used (35 patients per group). Patients graded their pain on a level of one to 10 at different stages throughout the procedure.
According to the researchers, there was no significant difference in the duration of surgery and demographic variables among the groups. During the intraoperative period, at the end of the surgery, and in the first hour postoperatively, however, the mean verbal pain score was significantly higher in the lidocaine group. Researchers also found that surgeons' and patients' satisfaction scores were significantly better in the levobupivacaine and ropivacaine groups compared with the lidocaine group. Pain levels at the time of incision and 24 hours postoperatively were not significantly different in any group.
"Levobupivacaine and ropivacaine provided significant and long-lasting analgesia without the need of supplemental anesthesia for each patient," according to the researchers.
New ASCRS President Addresses Medicare Reform
Bradford J. Shingleton, MD, of Boston assumed the duties of President of the ASCRS, according to a press release from the organization. Dr. Shingleton is a glaucoma and cataract specialist and a surgeon in ophthalmology at the Boston Eye Surgery & Laser Center, the Cape Cod Eye Surgery & Laser Center. He also maintains privileges at Massachusetts General Hospital and the Massachusetts Eye and Ear Infirmary.
According to the release, Dr. Shingleton believes there is a need for Medicare reform. "The formulas used to calculate doctors' reimbursements under Medicare are a time bomb," Dr. Shingleton said in the release. "There has been a steady ratcheting down of reimbursements for doctors' services. These reductions, in the face of rising costs and inflation, threaten to make it impossible for many physicians to continue providing services to Medicare patients," he said.
"We have a Medicare system that is failing: we must be proponents of solutions, and we need to be bold in presenting them," Dr. Shingleton said. As a nation, it is clear that we simply cannot afford to provide every patient with the latest, highest-cost services and technology as part of basic care". Instead, he suggested, the system should provide high-quality basic care, with an expanded patient-shared payment responsibility for special elective services.
FDA Approves Ophthalmic Solution
The FDA has approved an Abbreviated New Drug Application for diclofenac sodium ophthalmic solution 0.1% (Akorn, Inc., Buffalo Grove, IL).
Diclofenac sodium ophthalmic solution is a NSAID used to treat cataract and refractive surgery patients. Annual sales for the ophthalmic solution were approximately $14 million in 2007, according to a company news release.
The product is expected to be launched in the second quarter of 2008, according to Arthur Przybyl, Akron's President and Chief Executive Officer
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