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CRSToday Europe News — November/December 2007
LASIK TÜV Certification
As patients look for the right clinics and proof of quality surgical outcomes, medical professional associations in Germany have developed a certification for treatment centers to attempt to erase any lingering skepticism among the approximately 52 million Germans who suffer from myopia, hyperopia, or presbyopia.
The Organization of German Specialty Clinics for Eye Laser and Refractive Surgery, in conjunction with the Ophthalmologic Surgery Task Force, the Committee for Refractive Surgery, and third-party quality certification company TÜV SÜD, have joined to create a criteria catalog by which to measure LASIK centers throughout the country.
The thought was that many people with refractive error refrain from undergoing LASIK because they find it difficult to choose a surgery center or treatment option; there are more than 300 eye centers in Germany. With the LASIK-TÜV certification mark in place, however, patients should have a better sense of a center before they even step through the door.
LASIK TÜV is primarily designed to certify top-level providers, mainly due to the requirement of large surgical volume and a surgical spectrum encompassing both laser and lenticular refractive surgery. LASIK TÜV was discussed during the 2007 meeting of the German Ophthalmic Surgeons (DOC) in Nürnberg. The discussion was somewhat controversial, because "of approximately 300 refractive surgeons, only 15 centers are currently certified for LASIK TÜV," said Michael Knorz, MD, of Mannheim, Germany.
LASIK TÜV consists of two components: The base component is the internationally accepted certification according to ISO 9001:2000, which certifies the process, not the outcome. The second component, which can only be obtained once the first has been awarded, is outcome-based and has been branded LASIK TÜV. It measures the standards of hygiene and focuses on the personal qualification of the staff as well as on the outcome of the surgery, both measured by visual results and by patient satisfaction.
LASIK TÜV requirements include: providing evidence that a surgeon has performed more than 1,000 surgeries in the past 5 years and at least 250 LASIK surgeries or 150 LASIK and 300 intraocular procedures in the past year; providing evidence that the respective center offers LASIK as well as lenticular refractive surgery; providing evidence that treatments are performed within approved ranges only (myopia up to -10.00 D, to be calculated as the sum of sphere and cylinder, hyperopia up to 4.00 D, and astigmatism up to 5.00 D); providing proof of good complications management, a complication rate of less than 1% and an enhancement rate of less than 15%; and providing refractive outcomes within ħ0.50 D for 90% of myopes up to -6.00 D and 80% of hyperopes up to 3.00 D.
Centers must also be required to meet specific requirements set by the LASIK TÜV on its equipment, management structure, and qualifications of employees.
The LASIK TÜV as well as the ISO 9001:2000 certification are valid for 2 years, with audits by the TÜV SÜD every year and recertification every 2 years.
Corneal Cross-Linking Explored for Treating Ectasia
Physicians continue to explore ophthalmic applications for collagen cross-linking in the cornea with riboflavin.1 The technique involves penetrating the epithelium (achieved one of three ways), instilling riboflavin to the cornea, and then applying UV radiation to activate collagen thickening. Using the technique for ectasia involves the anterior 300 µm of the cornea, regardless of whether the ectasia is the result of forme fruste keratoconus or a thick flap, because cross-linking takes place in both the stromal bed and the overlying flap.
Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed) of London, and colleagues have treated seven eyes with post-LASIK ectasia using a device to perforate the epithelium before applying the riboflavin. They ensure an adequate absorption of riboflavin and a corneal thickness of at least 400 µm before applying the UV radiation. Initial results have shown a small subjective improvement in visual acuity and a decrease in visual fluctuations. They also observed a decrease in central corneal thickness that they attributed to collagen fibril thickening and consequent shortening and also a transient loss of keratocytes. Although the investigators did not see an improvement in keratometry, they reported that the corneas stabilized or at least showed a considerably slowed rate of progression. Despite a risk of UVA toxicity with this procedure, the investigators consider cross-linking with riboflavin to be a promising and useful option for treating post-laser refractive ectasia.
AcuFocus: Safe and Reversible Procedure for Presbyopia Correction
Günther Grabner, MD, an investigator in the European AcuFocus ACI 7000 (AcuFocus, Inc., Irvine, California) trial, reported that his results matched those of the 175 patients enrolled in the US Food and Drug Administration (FDA) clinical study.1
"I think the [AcuFocus ACI 7000] is a very effective technique for the correction of presbyopia," Dr. Grabner said. "It has great potential for presbyopic patients who are post-LASIK. … It is minimally invasive, stable, and well tolerated."
A total of 70 patients are enrolled in the European study. All patients have been followed for at least 1 year. Postoperative distance UCVA remained unchanged from preoperative measures, and on average, near UCVA improved from J7/8 to J2. Sixty-five percent of patients were seeing J1 or better at 6 months.
"Visual acuity improves slowly," Dr. Grabner said. "It takes about 6 months for the patients to really improve."
Three of Dr. Grabner's 37 patients required recentering. Approximately 3 months afterward, distance and near visual acuity improved, and all patients returned to 20/20. Dr. Grabner and colleagues hypothesize that the upper tear meniscus is the cause of the 0.5-mm displacement. "By placing the implant a little bit downward and inward, we might be out of the way of the tear meniscus, and we may not have to recenter the implant," Dr. Grabner said.
Zeiss Acquired Acri.Tec, Settled Patent Dispute
Carl Zeiss Meditec AG (Jena, Germany) has completed its acquisition of Acri.Tec AG (Berlin, Germany). Acri.Tec manufactures the Acri.LISA refractive-diffractive multifocal and the Acri.Smart microincisional cataract surgery IOLs.
In a news release, Ulrich Krauss, Carl Zeiss Meditec AG's President and CEO said that the addition of Acri.Tec's IOLs to Zeiss' portfolio would allow his company to "cover the entire spectrum of IOLs—ranging from simple monofocal IOLs for the treatment of cataracts to technologically sophisticated multifocal and microincisional lenses for refractive surgery."
The IntraLase subsidiary of Advanced Medical Optics, Inc. (AMO; Santa Ana, California), reported that it issued a nonexclusive, royalty-bearing license that allows Carl Zeiss Meditec AG to use IntraLase's patent portfolio to provide femtosecond technology for corneal surgery. The introduction of Zeiss' VisuMax femtosecond laser system during the 2006 AAO Annual Meeting in Las Vegas prompted IntraLase Corp., which was in the process of being acquired by AMO, to file a lawsuit. The lawsuit claimed that "Zeiss breached an intellectual property agreement with IntraLase by improperly using confidential and proprietary information of IntraLase, which Zeiss wrongfully induced IntraLase to disclose."
In January 2007, the FDA cleared the VisuMax femtosecond laser for the creation of corneal flaps during refractive surgery. The laser can also be used to perform femtosecond lenticule extraction, an investigative, all-in-one refractive procedure that reshapes the cornea without excimer laser ablation.
Laser Market Grew in More Positive Climate
A survey jointly conducted by the British Society of Refractive Surgery and supported by the Eye Laser Association revealed that after years of negative publicity and parliamentary scrutiny, reports of clinical outcomes have been largely positive in the past 12 months.
The report identified 105 clinics in the United Kingdom this year, 10 more than in 2006 and 2005. The increase in clinics follows 4 consecutive years of little or no net growth. The number of clinics, however, has more than doubled since the first survey was conducted in 2001. According to the survey findings, Ireland has experienced the biggest growth in recent years; its total number of clinics is at least 20.
Rapid expansion and the arrival of high-street clinics in Ireland, however, has raised fears of increasing commercialization of the sector and has prompted calls for stricter regulations.
The report also revealed that LASIK is still the most common treatment provided in the United Kingdom. Clear lens extraction, however, has now overtaken LASEK as the second-most common treatment. Additionally, the survey found that the average charges for LASIK increased this year and still vary widely among clinics.
The Optical Express and UltraLase laser eye clinics have also expanded in the past year. These companies now operate 60 locations between them, 10 more than last year, and account for nearly six out of 10 clinics in the United Kingdom. The full findings of this report can be found in Optician.
Public Takeover Period of WaveLight AG Ended
The Alcon Laboratories, Inc. (Fort Worth, Texas) public takeover period for WaveLight AG (Erlangen, Germany) has ended, leaving Alcon with 77.4% of the approximately 6.6 million outstanding WaveLight shares. The number of WaveLight shares tendered to Alcon under its previous takeover offer was 3.1 million, or 47.5%. Alcon had also purchased 2 million shares (29.9%) in the market or directly.
"I am very pleased with this result," commented Cary R. Rayment, Alcon President and CEO. "It enables us to integrate WaveLight operations with Alcon's global capabilities and create a leading force in the refractive laser market."
Solid-State Laser Promising
According to an AAO news release, clinical data suggest that the solid-state CustomVis Pulzar Z1 excimer laser (CustomVis, Perth, Australia) affords similar or superior refractive surgery results as compared with commercially available wavefront-guided lasers.
In contrast to traditional excimer lasers that ablate at 193 nm, the Pulzar Z1 ablates at a wavelength of 213 nm, which is close to the peak absorption of corneal collagen and is significantly less absorbed by 0.9% NaCl and balanced salt solution. Therefore, fluctuations in corneal hydration are not a significant concern, according to the news release.
Decagonal Transplant Shape in Perforating Keratoplasty Delivered Promising Long-Term Results
In a 2-year postoperative analysis of 30 patients who underwent perforating keratoplasty with the Femtec laser (20/10 Perfect Vision AG, Heidelberg, Germany), Mark Tomalla, MD, of Druisburg, Germany, reported good postoperative results.
The use of the femtosecond laser enabled the surgeon to select the diameter of the transplant and the cutting angle; each is specifically adapted to the patient, Dr. Tomalla said. This tailors the keratoplasty to the specific conditions of each patient's eye.
The next step was to address the optimal transplant shape, Dr. Tomalla said.
"We have now performed the first three perforating keratoplasties with a decagonal shape. This type of transplant could be sutured into the recipient cornea with a precise fit of 1/100 mm."
The advantages of the decagonal cut compared with a round or oval transplant is that there is no rotation or decentration during suturing. Additionally, a fixation suture can be omitted in suturing, and a double suture is no longer required.
"Two months postoperatively, we found stable refractive values in our patients with decagonal transplant shapes," Dr. Tomalla said. Mean astigmatism was 2.00 D, and fine Descemet folds—visible immediately postoperatively—disappeared 2 weeks postoperatively.
"In our opinion, the use of noncircular transplant shapes, such as the decagonal shape, is a very promising approach," Dr. Tomalla wrote in an e-mail to CRST Europe.
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