|
CRSToday Europe News – September 2009
Focusing on Spectacle Independence: Is it Practical for Refractive Surgery?
Spectacle independence is promoted as an achievable outcome for many refractive procedures and IOL implantation surgeries. Even presbyopic patients hope to attain spectacle freedom. Cataract & Refractive Surgery Today Europe contacted members of the ophthalmic community to find out if the emphasis on spectacle independence has increased the rate of refractive surgery in candidates outside currently accepted treatment zones.
"I do not think that the focus on spectacle independence is affecting the ophthalmic industry negatively. In fact, if well managed, it can positively influence our profession," wrote Roberto Pinelli, MD, in an e-mail to CRST Europe. Dr. Pinelli is the Scientific Director of ILMO, Brescia, Italy, and a member of the CRST Europe Editorial Board. He is also a member of the Executive Committee of the International Society of Refractive Surgery of the American Academy of Ophthalmology (AAO).
Because refractive surgery has advanced in terms of the quality of options for patients, the percentage of patients who are poor candidates for procedures is much lower than just 5 years ago, Dr. Pinelli pointed out. Similarly, patients who are poor candidates for one technique can potentially benefit from another, he said.
From Dr. Pinelli's perspective, the rapid advances in IOL technology require refractive surgeons to adopt a new attitude regarding the development of patient relationships. "We must engage in more dialogue with our patients and work with them to clarify their goals for vision correction. If we do this and teach incoming generations of surgeons to do the same, the spectacle independence message will not become a problem."
The most important element a surgeon can bring to the physician-patient relationship is honesty, Erik L. Mertens, MD, FEBOphth, wrote. Dr. Mertens, the Associate Medical Editor of CRST Europe, is Medical Director of Medipolis, Antwerp, Belgium, and of FYEO Medical, Eersel, Netherlands. "Performing surgery on eyes that fall outside established treatment zones is simply never acceptable, especially on the grounds of spectacle independence. Patients will be most grateful if you are honest about what is possible for them."
Simonetta Morselli, MD, agrees that it is the responsibility of the refractive surgeon to actively work with patients to identify their surgical needs and discuss all possible outcomes. But, she said, some surgeons perform refractive procedures on poor candidates, and this reflects negatively on the ophthalmic industry. "Some refractive ophthalmologists give incorrect indications for surgery because they are ignorant, but some do it because they are influenced by money and know that patients will pay for spectacle independence." Dr. Morselli is Head of the Ophthalmic Unit of the San Bassiano Hospital, Bassano Del Grappa, Italy. She is also a member of the CRST Europe Editorial Board.
Dr. Morselli warns that patients who were "wrongly treated" often do not hesitate to share their negative experience with others. "The good that we can do for many patients' quality of life can be tainted by those surgeons who inappropriately treat patients based on greed," she said.
To some extent, patients are willing to pay for spectacle independence because the ophthalmic market has turned LASIK and IOLs, for example, into consumer goods, commented CRST Europe Editorial Board member A. John Kanellopoulos, MD, Director of Laservision Eye Institute in Athens, Greece. Dr. Kanellopoulos also practices in New York, as an Attending Surgeon in the Department of Ophthalmology at the Manhattan Eye, Ear, and Throat Hospital in New York and as a Clinical Associate Professor of Ophthalmology at New York University Medical School.
Dr. Kanellopoulos acknowledges the advances made in ophthalmology, specifically in the area of visual rehabilitation for cataract patients as well as for refractive ammetropias such as myopia, hyperopia, and/or astigmatism. At the same time that these procedures have become safe, simple, and effective, Dr. Kanellopoulos noted, they have also become "consumer products" marketed to treat certain indications. "These procedures have become so commonplace that the medical foundation inherent to them and their associated technologies is often underestimated," Dr. Kanellopoulos wrote in an e-mail to CRST Europe. "This creates a misconception among patients and undermines the integrity of our field."
Acuvail Approved for Postop Pain and Inflammation
Acuvail 0.45% (ketorolac tromethamine ophthalmic solution; Allergan, Inc., Irvine, California) has been approved by the US Food and Drug Administration (FDA) for the treatment of pain and inflammation following cataract surgery. According to the company, this preservative-free NSAID is formulated with a pH of 6.8 to enable deionized drug delivery to the corneal surface and contains carboxymethylcellulose to promote adherence to the ocular surface.
Additionally, the solution reportedly provides comprehensive inhibition of the COX-1 and COX-2 enzymes to hinder the development of prostaglandins.
Two multicenter, randomized, double-masked, parallel-group, comparative studies involving more than 500 individuals showed that, at day 7, nearly twice as many patients receiving Acuvail had a summed inflammation score of zero compared with patients treated with vehicle (32% vs 17%). Significantly more patients in the Acuvail group exhibited clearing of inflammation in the anterior chamber at day 14 compared with patients in the vehicle group (53% vs 26%). The drug was also significantly superior to the vehicle in resolving ocular pain after cataract surgery.
Ophtec to Debut Three IOLs at ESCRS
Opthec BV (Groningen, Netherlands) announced that it will introduce three IOLs at the annual meeting of the European Society of Cataract & Refractive Surgeons (ESCRS) in Barcelona, Spain. The Toric Artiflex PIOL can correct cylinder of -1.00 to -5.00 D in combination with a spherical correction of -1.00 to -13.50 D. Two aspheric IOLs, the Luna, a hydrophobic acrylic lens, and the QuadrimaX, a hydrophilic acrylic IOL, will also be introduced.
Allegretto Wave Approved in Japan; First UltraFlap Procedure Performed
WaveLight AG (Erlangen, Germany) received regulatory approval for the 200-Hz Allegretto Wave excimer laser system by Japanese authorities, according to a news release. The laser was approved for wavefront-optimized LASIK treatments of myopia and myopic astigmatism.
Wavelight AG also announced that Germany's ethics commission approved treatment with the company's UltraFlap Femtosecond laser for clinical testing. Christoph Winkler von Mohrenfels, MD, at the Technical University of Munich, Germany, performed the first LASIK treatment with the laser. The patient showed no postoperative abnormalities, and a smooth stromal bed and easy-to-lift flap were observed, the company said in a news release. In addition to flap creation, WaveLight plans to add applications to the UltraFlap Femtosecond for sub-Bowman's keratomileusis, intrastromal corneal ring segments, and lamellar keratoplasty (penetrating and self-sealing).
Alcon, AstraZeneca Collaborate on Drug Development
Alcon, Inc. (Huenenberg, Switzerland), has reportedly entered into a 5-year collaborative research agreement with AstraZeneca PLC (London) for the exclusive ophthalmic discovery and potential developmental rights to AstraZeneca's compound library. According to a news release, the agreement includes multiple classes of small molecules with lead compounds that have been identified as potential treatments for ophthalmic diseases such as ocular allergy, dry eye, and other inflammatory eye conditions as well as glaucoma and retinal diseases.
Under the terms of the agreement, Alcon has immediate access to AstraZeneca's compound library. AstraZeneca will reportedly hand over development and regulatory documentation for compounds identified as ophthalmic candidates, and Alcon will perform and fund all research and development activities to move selected compounds forward. The agreement allows individual licensing agreements to be negotiated on a case-by-case basis for any compound that enters clinical development, including regulatory milestone payments and royalties on product sales. The agreement does not preclude Alcon from pursuing compounds it develops itself or licenses from other companies prior to the initiation of phase 3 confirmatory clinical studies.
Crystalens HD Available in 0.25 D Steps; Akreos Launched in US
Bausch & Lomb (Rochester, New York) received US FDA approval to market the Crystalens HD in 0.25 D steps in the United States and Europe. Quarter diopter steps will be available for the models HD500 and HD520 in the ranges of 18.00 to 22.00 D. The availability of a wider range is expected by the end of 2010, according to a company news release. Bausch & Lomb reportedly began shipping the Crystalens HD in the additional dioptric steps in July.
In other company news, Bausch & Lomb Surgical launched the Akreos AO Micro Incision Lens (MI60L), also known as the Akreos MICS IOL, in the United States. According to a company news release, the spherical, aberration-free lens is designed for implantation through a 1.8-mm incision.
Perioperative Brimonidine Increased Flap Dislocation
Brimonidine tartrate 0.2% (Alphagan; Allergan, Inc.) prevented the formation of subconjunctival hemorrhages after femtosecond LASIK but increased the risk for flap dislocation, according to a study in the Journal of Cataract & Refractive Surgery.1
In a prospective, contralateral-eye, interventional study, Gonzalo Muñoz, MD, PhD, FEBO, and colleagues at the Centro Oftalmológico Marqués de Sotelo and Hospital NISA Virgen del Consuelo, in Valencia, Spain, evaluated 136 eyes of 68 consecutive patients who underwent bilateral simultaneous femtosecond LASIK for myopia (range, -1.00 to -8.00 D). One eye of each patient was treated with a single drop of brimonidine tartrate 0.2%. The control eye was treated with a single drop of balanced saline solution.
The incidence of subconjunctival hemorrhage was statistically significantly lower in the brimonidine group (mean score, 2.24 ±1.96 [standard deviation]) compared with the control group (mean score, 7.61 ± 2.72; P <.001), the study authors said. However, none of the eyes in the control group and seven eyes in the brimonidine group had a dislocated flap with folds on the first postoperative day (P =.016). All eyes with dislocated flaps required surgical intervention.
At 6 months, there was no significant difference between the groups in the percentage of eyes achieving 20/20 or better distance UCVA, in the mean spherical equivalent, or in the enhancement rate, the study said.
Based on the results of their study, the authors "caution against the use of perioperative brimonidine to decrease hemorrhagic complications in femtosecond LASIK."
Company to Operate Under New Name
US IOL manufacturer Ophthalmic Innovations International (Ontario, California) has changed its name to Aaren Scientific Inc. There has been no change in management, operations, production, or regulatory status, and the company will continue to provide its existing products and service, according to a company news release.
Recommendations to Reduce CXL Failure Rates
A prospective study showed that changing the inclusion criteria may significantly reduce the complication and failure rates associated with corneal collagen crosslinking (CXL) for primary keratectasia.1
Researchers in Switzerland evaluated 117 eyes of 99 patients with progressive keratectasia who underwent CXL. Of 105 eyes that completed the 12-month follow-up, three lost two or more Snellen lines of visual acuity. Keratectasia continued to progress in eight eyes. Investigators identified age (older than 35 years) and a preoperative distance BCVA better than 20/25 as significant risk factors for complications. A high preoperative maximum keratometry reading was a significant risk factor for failure.
"A preoperative maximum keratometry reading less than 58.00 D may reduce the failure rate to less than 3%, and restricting patient age to younger than 35 years may reduce the complication rate to 1%," the study's authors concluded.
UKISCRS Annual Meeting
The United Kingdom and Ireland Society of Cataract & Refractive Surgeons (UKISCRS) Annual Meeting will take place at the Royal Armouries, Leeds, United Kingdom, on October 8 and 9.
CRST Europe Chief Medical Editor Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed) is the Choyce medal lecturer. To view the complete conference program visit www.ukiscrs.org.uk.
– Compiled by Jennifer Kreatsoulas, PhD, News and Contributing Editor
|