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CRSToday Europe News – January 2009
Europe-Wide Registry to Benchmark Cataract and Refractive Outcomes
The European Society of Cataract and Refractive Surgeons (ESCRS) has partnered with 12 national ophthalmic societies to develop the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO). Supported by a 3-year grant from the European Union (EU), the registry aims to improve treatment and standards of care for cataract and refractive surgery and to build an European network to promote the exchange of best practices between physicians in their own regions and other countries.
EUREQUO originated from two independent quality registries supported by the ESCRS: the European Cataract Outcome Study (ECOS) and the Refractive Surgery Outcomes Information System (RSOIS). With the EU funding, the ESCRS and its partners will develop the infrastructure to enhance and combine these two registries into one Europe-wide database.
Each participating country will have a national registry with data collection from individual practitioners, small and medium-sized clinics, large hospitals, and university institutions. As information is recorded nationally, it will be processed and disseminated into the EUREQUO database, making it possible to compare outcomes with the average across Europe. The participating countries will initially include Austria, Belgium, Denmark, Finland, Greece, Germany, Hungary, Ireland, Italy, the Netherlands, Norway, Slovakia, Spain, Sweden, Turkey, and the United Kingdom.
"Ophthalmologists can look at their own outcomes as well as the aggregated anonymous outcomes of other surgeons in their own and other countries," ESCRS President Paul Rosen, FRCOphth, said in an interview with Cataract & Refractive Surgery Today Europe. "This outcomes registry will produce the Europe-wide benchmark by which people can assess themselves and improve their clinical practice."
All information is collected and stored anonymously, so an individual will be able to look at his own outcomes but they cannot view that of another colleague.
In April 2009, EUREQUO will start up in three pilot countries—Scandinavia, Holland, and Spain. The pilot phase will allow the ESCRS and its partners to assess the implementation of the database, the functionality of the interface, and if the right information is being collected. Given that European surgeons may use any of four methods of collecting visual acuity outcomes, part of the pilot phase will also include determining how to make the registry work for everyone. The following year, the registry will expand to 10 European countries—and eventually to any country that wishes to participate.
Many registries already exist throughout Europe. For example, in Holland, a registry database is required for insurance reimbursement. Dr. Rosen anticipates that this type of requirement will become more prevalent in European countries, including the United Kingdom. In this sense, Dr. Rosen said, the EUREQUO database is ahead of the game. "Unless you are actively collecting data and can tell insurers, whether private or government, how good [your outcomes are] they won't reimburse you."
There are many incentives for surgeons to use the registry. For example, ophthalmologists will be able to benchmark their own results. EUREQUO will provide those who do not currently collect their outcomes with a database for analysis.
Surgical results can be audited, which in some countries may be required for professional revalidation, malpractice insurer requirements, and insurance reimbursement. Users will also have the ability to form research networks via the database. Furthermore, entering data into EUREQUO will not be time-consuming or require additional work. Physicians' databases will automatically transfer their data into EUREQUO, avoiding double entry.
EUREQUO provides a means to audit surgical results (ie, a feedback loop) and so it will allow practitioners to make adjustments to their techniques and improve their outcomes. "The expectation is to provide people who spend time collecting data with the ability to analyze their outcomes, which could be used for presentations," Dr. Rosen explained. "On the national and international level, we will be able to see the scope of surgical procedures being carried out as well as their outcomes."
For further information, contact Lucia Brocato, EUREQUO Project Manager, at lucia.brocato@escrs.org.
Nonsteroidal Uveitis Drug Awaits Approval
The European Medicines Agency (EMEA) accepted the pediatric investigation plan (PIP) for Luveniq (Lux Biosciences, Inc., Jersey City, New Jersey), an oral formulation of voclosporin, according to a news release. Luveniq is in phase 3 development for sight-threatening noninfectious uveitis. The PIP, which is a prerequisite for European approval of a new drug, applies to patients with uveitis aged 2 to 17 years.
Data from Lux Biosciences' clinical trial program, LUMINATE (Luveniq Uveitis Multicenter Investigation of a New Approach to Treatment) reportedly will be published in early 2009. LUMINATE consists of three randomized, placebo-controlled, double-masked studies of 560 adults with noninfectious uveitis at 58 sites in seven countries. Luveniq will be the first steroid-free therapy for uveitis if the United States and European regulatory agencies approve it.
Global Burden of Presbyopia
Presbyopia affects more than an estimated 1 billion people globally, according to an analysis of multiple population-based surveys in the Archives of Ophthalmology.¹ That figure is projected to increase to 1.4 billion by 2020 and to 1.8 billion by 2050.
Of the 1 billion people currently affected by presbyopia, 517 million do not have adequate near vision correction, of whom 410 million (94% of whom live in developing countries) have a significant near-vision disability and could benefit from spectacles. According to investigators, "access to spectacles in [developing] countries is limited by insufficient numbers of health care professionals able to perform relevant eye examinations, a lack of available, affordable spectacles, and a lack of adequate public health support structures to help people obtain spectacles."¹ If spectacles are not made more accessible in these countries, researchers project that the number of individuals globally who will be disabled due to uncorrected presbyopia will increase to 563 million by 2020.
The researchers stated that additional epidemiological study is needed to generate a more accurate global estimate of those affected by presbyopia. Based on their findings, however, the investigators recommended that "a provision of human resources, affordable spectacles, and systems of delivery" be instituted in developing countries to help combat the growing visual problem in these regions.¹ Additionally, they proposed that primary eye care providers include refractions and evaluations for glaucoma and diabetic eye disease because patients with these diseases are generally affected by presbyopia.
Type of Error Predicts Corneal Thickness, Elevation
A prospective study that evaluated elevation and thickness data in patients with different refractive errors suggested that eyes with high myopia had thinner corneas and deeper anterior chambers than emmetropic eyes.¹
Ömür Ö. Uçakhan, MD, and colleagues at the Ankara University Faculty of Medicine, Turkey, took corneal topography measurements (Pentacam; Oculus Optikgeräte GmbH, Wetzlar, Germany) of the right eye of 215 consecutive patients with refractive errors and of the right eye of 31 healthy emmetropic volunteers.
Eyes with high myopia had significantly lower mean corneal thickness and volume measurements and higher mean anterior chamber depth (ACD) and anterior chamber volume (ACV) measurements than eyes with myopia, hyperopia, or astigmatism. The mean ACD, ACV, and anterior chamber angle were significantly lower in hyperopic eyes than in eyes with other refractive errors. Investigators found that the mean keratometry readings were statistically significantly flatter in hyperopic patients compared with patients with other refractive errors (P<.001). Elevation measurements of eyes with myopic refractive errors did not differ from each other or from those in emmetropic eyes, the study authors found.
Thin-Flap as Good as Thick-Flap LASIK in Two Studies
Retrospective analyses suggested that sub-Bowman's keratomileusis (SBK) is as safe, efficacious, and predictable as thick-flap LASIK in corneas with equivalent residual stromal thickness, according to a paperin the Journal of Cataract & Refractive Surgery.¹
Researchers at the Massachusetts Eye and Ear Infirmary in Boston performed two studies that included patients who underwent LASIK for moderate to high myopia (n=144; -4.00 D to -10.00 D), had completed a follow-up visit at 3 months or more, and had preoperative astigmatism of 3.00 D or less. The first study compared 30 patients (33 eyes) who had SBK and a flap thickness of between 82 and 120 µm with 53 patients (62 eyes) who had thick-flap LASIK with a flap thickness of 160 µm or more. In the second study, eyes that underwent SBK were matched with eyes that had thick-flap (greater than 144 µm) LASIK. Case-control matched comparisons of residual stromal bed thickness were performed for 21 matched pairs.
In the first study, the mean flap thickness was 110.2 ±9.2 µm in the SBK group and 179.2 ±19.5 µm in the thick-flap LASIK group. Investigators did not observe significant differences in visual outcomes between the two groups. No eye in either group lost two or more lines of BCVA, but 27.3% of eyes in the in the SBK group lost one line of BCVA compared with 8.1% of eyes in the thick-flap LASIK group (P=.01). Although there was a higher rate of retreatment in the SBK group (24.2%) than in the thick-flap LASIK group (19.4%), the difference was not significant (P=.58).
The second study, a case-control matched comparison of residual stromal bed thickness between the SBK group (mean 108.6 ±8.0 µm) and the thick-flap LASIK group (mean 165.7 ±12.6 µm), showed no differences in preoperative and postoperative refractive and visual outcomes. Also, no significant differences between the intended versus achieved correction was found between the two groups (P=.44). According to the investigators, these findings suggest that "corneal flap thickness does not affect the refractive outcome in patients with adequate residual stromal bed thickness."¹
ICL Accommodative Function Rebounded at 1 Year
The amplitude of accommodation decreased in eyes implanted with the Visian ICL (STAAR Surgical Company, Monrovia, California) but returned almost to baseline by 1 year postoperative, according to a prospective nonrandomized trial. Researchers also investigated the relationship between patients' age and their level of accommodation after receiving the ICL.¹
Investigators at the University of Kitasato in Kanagawa, Japan, examined 69 eyes of 40 consecutive patients with myopic refractive errors between -3.25 and -22.75 D who were undergoing ICL implantation. At baseline, mean accommodation was 6.36 ±3.94 D. Mean accommodation decreased at 1 month (4.89 ±2.72 D) but began to increase by 3 months (4.98 ±2.67 D). Mean accommodation continued to increase at 6 months (5.16 ±2.72 D) and returned nearly to baseline by 1 year (5.72 ±2.85 D).
The researchers reported that the variance in data was statistically significant (P=.02). Multiple comparisons demonstrated significant differences between measurements made before surgery versus 1 month postoperatively (P=.004), before surgery versus 3 months postoperatively (P=.007), and before surgery versus 6 months postoperatively (P=.01). There was a significant correlation between patients' age and accommodation before and 1 year after ICL implantation (P<.001).
These results "may be attributed to transient dysfunction of the ciliary muscles by ICL fixation to the sulcus even if the crystalline lens remained untouched," the study's authors concluded. "The amplitude of accommodation is decreased with aging in ICL-fixated eyes as well as normal eyes." A long-term study is needed to confirm that accommodation is maintained continuously after 1 year, the investigators stated.
Two Populations of Stromal Nerves Discovered
Laser scanning in vivo confocal microscopy revealed two morphologically distinct stromal nerve populations in the normal human cornea, according to a study in the British Journal of Ophthalmology.¹
Researchers at the University Medical Centre Utrecht, Netherlands, analyzed in vivo confocal microscopy (Heidelberg Retina Tomograph II Rostock Corneal Module; Heidelberg Engineering GmbH, Dossenheim, Germany) images of the central cornea of 99 eyes (99 healthy patients). The mean age of the group was 34.7 ±13.3 years (range, 13–84 years). Investigators identified straight, dichotomous branching nerves, and tortuous nerves with a beaded appearance. The mean recorded depth of straight stromal nerves was significantly deeper than the mean depth of the tortuous stromal nerves (186 ±66 µm vs 140 ±87 µm, respectively; P<.001).
The authors hypothesize that the two morphological nerve populations may represent functionally diverse nerves. Further research is needed to determine if these two populations of stromal nerves represent different types of sensory nerves, the authors concluded.
Awards and Appointments
Rolf Schwind, Chief Executive Officer of Schwind eye-tech-solutions (Kleinostheim, Germany) received the Gusi Peace Prize 2008 for outstanding achievement in the field of industry and innovation. The Gusi Peace Prize Foundation is a nonprofit organization located in Manila, Philippines. Each of 15 prize winners were recognized for their outstanding merits in medicine, physics, chemistry, economics, politics, art, or journalism, and their contribution to peace, advancement, and the preservation of human rights. Mr. Schwind was honored for his company's goal to improve vision and the innovative qualities of the Schwind Amaris.
"I received this award as a representative of the whole Schwind team, who constantly concentrate on setting outstanding technological and clinical standards in refractive surgery. All together, four prizes were awarded to Schwind in 2008. I am happy that all juries involved confirmed the special position of the company and the Schwind Amaris with their decisions," Mr. Schwind wrote in an e-mail to Cataract & Refractive Surgery Today Europe. "Since the introduction of the Schwind Amaris in September 2007, this innovative laser has, according to many experts, established itself as the technological leading laser system in refractive surgery. It is the first and only eye laser worldwide to combine all available modern technology in one system, thereby offering unequaled high-performance features regarding laser parameters, eye tracker, safety, and ergonomics."
Visiogen, Inc. (Irvine, California), appointed Mitch C. Hill as the company's Chief Financial Officer. Before this appointment, Mr. Hill was Executive Vice President and Chief Financial Officer at InSight Health Services Holding Corporation (Lake Forest, California). Mr. Hill also held senior financial positions at several other companies, including Goldman Sachs (New York, New York).
Holger Heidrich, PhD, was elected to the Board of Directors of Eucomed, the largest association of companies from the field of medical device technology in Europe. This organization represents the interests of more than 1,500 companies from different European fields of medical device technology. Dr. Heidrich is President of Europe/Africa/Middle East & International Government Affairs at Advanced Medical Optics, Inc. (Santa Ana, California). He is the first member of the ophthalmic industry to be elected to the board of Eucomed.
– Compiled by Jennifer Kreatsoulas, News and Contributing Editor
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