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CRSToday Europe News – June 2009

Charity Foundation Will Set Up 100 Cataract Centers in China by 2015
Although economic reform in China has resulted in a tenfold increase in gross domestic product (GDP) since 1978, the country's cataract surgical rate (CSR; ie, the number of cataract operations per million citizens per year) is among the lowest in the world.1 As of December 2006, China, with a population of approximately 1.3 billion, had a CSR as low as 380, according to data from the Vision 2020 Global Declaration.1 China has more than 5 million citizens with bilateral cataract blindness, which comprises approximately 18% of the world's blind population.2

The primary reason for the low CSR in China is the gap between the demand for cataract surgery in villages and the supply and cost of service in cities. Service is not available in the villages and not affordable for rural dwellers in the city. This creates a city-village barrier that prevents rural residents from receiving cataract surgery.

To tackle China's low CSR and address the city-village barrier, Dennis S. C. Lam, MD, FRCOphth, FHKAM, created the Project Vision Foundation in Hong Kong in 2006. "The objective of Project Vision is to establish financially sustainable charity eye centers in rural areas where local doctors are trained to provide quality cataract surgery at an affordable price to their home community," Dr. Lam wrote in an e-mail to Cataract & Refractive Surgery Today Europe.

Dr. Lam is a Professor in the Department of Ophthalmology and Visual Science at the Chinese University of Hong Kong.

To date, 14 charity eye centers (including six from the Caring-is-Hip program, the pilot design for Project Vision) have been established in four rural provinces of China, including Inner Mongolia, Shaanxi, Guangdong, and Hainan. More than 15,000 cataract operations have been performed. By 2015, Project Vision hopes to establish 100 sustainable charity eye centers, reaching residents in the most remote areas of the country.

For every 1 million Hong Kong dollar donation (approximately €100,000), a charity eye center is set up at a county hospital in collaboration with the local government. Each center is equipped to serve a treatment area of 1 to 3 million citizens. The hospitals provide basic facilities and support for the charity eye centers. Patients are charged reduced fees for cataract surgery, making the procedure affordable for rural residents.

With donations to the Project Vision Foundation, equipment and medical supplies are purchased for the centers. Cost efficiency is achieved by purchasing consumables in bulk, minimizing administrative expenses, and reducing taxes on various imported equipment, Dr. Lam explained.

In the future, Dr. Lam wants to expand the foundation's surgical capabilities. "We hope to go beyond cataract blindness and offer treatments for other prevalent sight-threatening conditions, such as glaucoma and diabetic retinopathy, to those who reside in the rural villages of China," Dr. Lam told CRST Europe. Following the establishment of more charity eye centers in China, Dr. Lam plans to apply the same model in other developing countries. "The Project Vision cataract surgeons and our patients are starting to see some light at the end of a long, dark tunnel of avoidable blindness in China," he said. "'Give a man a fish, he eats for a day; teach a man to fish, he eats forever.' These words capture the essence of Project Vision—a self-empowerment scheme that can enable professionals around the world to help millions of blind people see the beautiful world again."

For more information on the Project Vision Foundation, to learn how you can volunteer, or to make a donation, please visit www.projectvision.org.hk.

Post-LASIK Quality of Life Study Reports High Patient Satisfaction
An analysis of the global peer-reviewed literature found that more than 95% of patients were satisfied with the outcome of their LASIK surgery.1 The retrospective literature review was done in preparation for a prospective study to be conducted by the US Food and Drug Administration (FDA), the American Society of Cataract and Refractive Surgery (ASCRS), the American Academy of Ophthalmology (AAO), and the National Eye Institute. Both the completed retrospective study and the future prospective study are a part of the Joint LASIK Study Task Force's mission to provide insight into the incidence of patients' dissatisfaction with modern LASIK, the causes, and possible treatments.

The literature review included all articles published on LASIK in peer-reviewed journals from 1988 through 2008. At the outset, investigators identified 2,915 LASIK-related abstracts. Following multistage, systematic elimination, they selected 309 articles that represented well-designed, properly conducted, randomized clinical trials or case control and cohort studies. Nineteen of these articles reported on patient satisfaction. Published from 1996 through 2007, the articles represent surgeries performed from 1995 to 2003 on 2,198 patients. Follow-up ranged from 1 month to 5 years. Patients' ages reportedly ranged from 18 to 67 years. The spherical equivalent treated ranged from 7.00 to -22.75 D.

Overall, patients' rate of satisfaction after primary LASIK surgery was 95.4% (2,097 of 2,198 patients; range of satisfaction, 87.2% to 100%). The rate was 95.3% (1,811 of 1,901 patients) after myopic LASIK and 96.3% (286 of 297 patients) after hyperopic LASIK. The overall rate of dissatisfaction was 4.6% (101 of 2,198 patients; range of dissatisfaction, 0% to 12.8%).

"Although LASIK generates the highest level of patient satisfaction of any elective surgical procedure, there still remains 4% to 5% of patients who are dissatisfied with their outcomes," Richard L. Lindstrom, MD, said in an e-mail to CRST Europe. "According to this extensive global review of the literature, the primary reasons for patient dissatisfaction following LASIK are residual refractive error, dry eye, and night vision symptoms." Dr. Lindstrom is a founder and attending surgeon at Minnesota Eye Consultants, PA, in Bloom-

ington, Minnesota. He is also a co-chair of the Joint LASIK Study Task Force.

"In most cases, residual refractive error can be treated with a laser enhancement," Dr. Lindstrom explained. "According to this study, dry eye following LASIK rarely leads to patient dissatisfaction. I find post-LASIK dry eye difficult to predict preoperatively. Fortunately, it can usually be mitigated with medical therapy and should be treated aggressively. Newer studies suggest that wavefront-driven custom treatment and expanded optical zones can reduce night vision symptoms; however, there are still some patients who complain of these symptoms, and no preoperative test, including pupil size measurement, is predictive of this complaint. It is appropriate that these primary causes of reduced post-LASIK satisfaction are disclosed [to] patients preoperatively."

AMO Suspends Production of Healon D
Abbott Medical Optics Inc. (AMO; Santa Ana, California) has suspended the manufacture of Healon D. The product's manufacturing process limits AMO's ability to ensure a continuous supply of this ophthalmic viscosurgical device (OVD) to the market to meet customers' needs and avoid delays and backorders, Steve Chesterman, a spokesman for AMO, wrote in an e-mail to CRST Europe.

The company's action does not pertain to Healon D that has already been distributed to customers, only to future production. The manufacture of AMO's other Healon products will not be affected, Mr. Chesterman said. The company will continue to pursue offering a dispersive OVD to US-based customers and will continue to provide Healon, Healon GV, and Healon5 globally. AMO's Vitrax II dispersive OVD will remain available in Canada, Europe, and other select global markets.

Lenstar is Among Winners of Design Competition
The laser optical biometer Lenstar (Haag-Streit AG, Koeniz, Switzerland) received the Red Dot Design Award. This international award is granted to products by a panel of design experts. Candidate products are judged on innovation, functionality, and formal quality. Lenstar was among winners chosen from 11,000 submissions across 61 countries.

Oculus Introduces Lower-Priced Pentacams
Oculus Optikgeräte GmbH (Wetzlar, Germany), expanded its Pentacam portfolio to include three models with different software configurations to accommodate ophthalmologists' specific clinical and financial needs.

The Pentacam Basic comes with a basic software package, which includes Scheimpflug imaging, color refractive and topometric maps, the ability to compare examinations, tomography, keratometry readings, noncontact pachymetry measurements, anterior chamber depth measurements, and the angle in degrees. The Pentacam Classic is packaged with the basic software plus a package for both cataract and the refractive surgeons. These models include corneal wavefront analysis, 3D lens density analysis, and a cataract grading system. The Pentacam High Resolution comes with the most sophisticated software, including pachymetry, elevation-based keratoconus detection, and the Holladay Report.

Numerous hardware features, such as a motorized table, a flat-screen monitor, a personal computer, a wireless mouse, and a mini-keyboard are included. Optional modules and software upgrades may be added to the units.

Availability and configuration of the Pentacam models may vary in some European countries. For additional information, e-mail: export@oculus.de or call: +49 641 2005 0.

Alcon to Complete Acquisition of WaveLight AG
Alcon, Inc. (Huenenberg, Switzerland), announced that the company has achieved ownership of more than 95% of the share capital of WaveLight AG (Erlangen, Germany). Under the provisions of the German Stock Corporation Act, Alcon is deemed to be the principal shareholder of WaveLight's approximately 6.6 million issued and outstanding shares. Alcon intends to acquire all remaining outstanding shares in accordance with the squeeze-out provisions of German securities law. Under these provisions, shareholders owning at least 95% of a company's shares have the right to squeeze out the remaining minority of shareholders by compensating them adequately. Alcon intends to acquire the remaining shares following WaveLight's annual general meeting in August.

Hoya Corporation Appoints Head of Surgical Optics Division
Hoya Corporation (Tokyo) announced that Thomas A. Dunlap, MBA, has been appointed to the position of global president and chief executive officer of Hoya Surgical Optics, Inc. (Chino Hills, California). Mr. Dunlap has been a senior operating executive and leader in the ophthalmic industry for more than 30 years. He has held executive positions at American Hospital Supply Corp. (Maitland, Florida), Allergan, Inc. (Irvine, Caifornia), and Bausch & Lomb (Rochester, New York). Most recently, he was the executive vice president of Sand Hill Consulting Associates (Santa Rosa, California). Mr. Dunlap was instrumental in the lobbying efforts of the Intraocular Lens Coalition, which led to the establishment of New Technology Intraocular Lens (NTIOL) designation for high-technology lens implants in the United States.

Tamsulosin Significantly Associated With Adverse Events After Cataract Surgery
A new study suggests that, in addition to causing surgical complications due to intraoperative floppy iris syndrome (IFIS),1 tamsulosin (Flomax; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut) increases patients' risk of developing serious postoperative complications following cataract surgery.2 Tamsulosin is an alpha-adrenergic receptor blocker indicated for the treatment of benign prostatic hyperplasia.

An analysis of 96,128 men who had undergone cataract extraction between 2002 and 2007 identified 284 (0.3%) patients who experienced an adverse event within 14 days postoperatively. Of the patients who experienced complications, 100 had suspected endophthalmitis. Additionally, 175 patients had undergone procedures to retrieve a lost lens or lens fragment from the vitreous body, 35 to resolve a retinal detachment, and 26 to address both of these adverse events.

When the investigators matched 280 of the patients who experienced adverse postoperative events with 1,102 control patients, they found that those who used tamsulosin were 2.3 times more likely to develop serious postoperative complications than those who were not exposed to the drug preoperatively. The investigators did not observe an increased risk of complications when nonselective alpha-blockers (ie, alfuzosin, doxazosin, and terazosin) were used.

"This is an interesting study conducted in the province of Ontario, Canada," wrote David F. Chang, MD, in an email to CRST Europe. Dr. Chang a member of CRST Europe's Global Advisory Board, is a Clinical Professor at the University of California, San Francisco, and is in private practice in Los Altos, California. "Because the province's universal health care system covers medications, the investigators were able to capture every surgical procedure and every prescription drug that was filled. Bell and colleagues2 found that patients taking tamsulosin had a 2.3 times higher incidence of serious postoperative complications. It should be noted that the study period includes surgeries done both before and after the initial description of IFIS."

"This is the first paper on IFIS to be published in the general medical literature," Dr. Chang added. "Although it is obvious to ophthalmologists that postoperative complications are more likely following posterior capsular rupture, primary care physicians do not really understand what this means. Specifically documenting 'retinal detachment, lost nuclear fragments, and endophthalmitis' as complications of tamsulosin/cataract surgery will better impress primary care physicians about the seriousness of this drug's side effects in cataract patients. These published findings may also encourage prescribing doctors to favor nonselective alpha-blockers in patients with a cataract."

Insert Improved Dry Eye Symptoms in Large-Scale Study
A multicenter study found that Lacrisert (hydroxypropyl cellulose ophthalmic insert; Aton Pharma Inc., Lawrenceville, New Jersey) significantly improved dry eye symptoms and quality of life.1 Bruce H. Koffer, MD, presented the results from this study at the 2009 Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Fort Lauderdale, Florida.

The multicenter, two-visit, open-label, 4-week study included 520 patients with dry eye. Overall, patients reported a significant reduction in the mean severity of their dry eye symptoms (P <.0001). After 4 weeks of Lacrisert treatment, mean ocular surface disease index scores (range, 0 to 100) improved by more than 21% from 41.8 ±22.38 at visit 1 to 32.9 ±21.97 at visit 2 (P ≤.0215). Treatment with Lacrisert resulted in a significant improvement in quality of life, specifically in the mean occurrence of discomfort in heated areas (P <.0001) and during the performance of housework (P =.0018). Lacrisert's effects reportedly lasted longer 93% of the time when compared with rewetting solutions.

Overall, the most common adverse event leading to the discontinuation of treatment was blurred vision, which was observed in 8.7% of patients (n=45).

Bruce H. Koffer, MD, is a consultant to Aton Pharma Inc.

CK Reduced Astigmatism and Improved Vision
Circular keratotomy (CK) significantly reduced astigmatism, improved BCVA, and stabilized astigmatic changes in most eyes with stage 1 and 2 keratoconus. However, eyes with higher preoperative astigmatism appear more likely to benefit from CK than those with lower preoperative astigmatism.1

Jorg H. Krumeich, MD, with the Klinik Krumeich in Bochum, Germany, and Guy M. Kezirian, MD, FACS, with SurgiVision Consultants Inc., in Scottsdale, Arizona, retrospectively analyzed 46 eyes (36 patients) operated on by one surgeon using CK from 1993 to 2006. The researchers observed a significant reduction in corneal and refractive astigmatism, particularly in eyes with preoperative astigmatism of 2.00 D or greater. Astigmatism stabilized for 28 eyes followed at 1 and 2 years after surgery. Of these 28 eyes, 94% had a change in astigmatism of 2.00 D or less between the 1-year follow-up and the last examination. Furthermore, mean BCVA improved from 20/44 to 20/33 (P <.01). Twenty (43%) of 46 eyes gained two lines or more, 22 (48%) of 46 eyes improved by less than two lines, and four (9%) of 46 eyes experienced a decrease in BCVA.

Oil-Based Marking Pens Hindered Flap Lifting
Oil-based ink may reduce the ability of the femtosecond laser to penetrate the cornea, according to Sonia H. Yoo, MD, of the University of Miami Miller School of Medicine, and colleagues. Dr. Yoo presented this finding at the 2009 ASCRS meeting in San Francisco.

The study, which Dr. Yoo shared with CRST Europe and which will soon be published in the Journal of Cataract & Refractive Surgery, compared the ease of lifting a femtosecond-laser–assisted flap (IntraLase FS Laser; AMO) after central corneal marking with oil-based (two groups) versus water-based (two groups) marking pens in 12 porcine eyes. In the oil-based pen groups, the corneal flap could not be lifted. In the water-based ink groups, the corneal flap was easily lifted.

"When used to mark the center of the cornea prior to flap creation, water-based ink provides greater ease of corneal flap lifting than oil-based ink," the investigators wrote. "Because the marking is located over the center of the pupil, any alteration of the cornea in this area from aggressive flap lifting may result in substantial visual loss. Therefore, the use of an oil-based ink must be avoided to mark the central cornea in order to avoid consequent traumatic irregularities of the flap stroma."

– Compiled by Jennifer Kreatsoulas, PhD, News and Contributing Editor






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