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People Who Have Had LASIK or PRK Can Be
Considered as Tissue Donors Later
ROCHESTER, Minn., December 2009 In a study to determine long-term changes in the cornea after LASIK and PRK, researchers found that the procedures had no long-term effect on the corneal endothelium.
They concluded that eyes that have had LASIK or PRK can therefore be considered as tissue donors for posterior lamellar keratoplasty, a type of corneal transplant.
The study involved 29 eyes of 16 people who had received myopia LASIK or PRK. The researchers analyzed photos of the cornea taken before the surgeries and nine years afterward, to check for cell loss. The mean annual rate of cell loss was not different from that in normal corneas.
A report of the study appeared in the November issue of Archives of Ophthalmology.
FDA Re-Opens Public Docket to Collect Information on LASIK Devices
SILVER SPRING, Md., December 2009 The FDA is re-opening a public docket to receive information and comments on LASIK devices. The previous year-long docket was open through Sept. 14, 2009. The new one will close on Nov. 15, 2010.
In an announcement in the Nov. 13 Federal Register, the agency said the submissions would help it improve its public outreach efforts regarding the safety and effectiveness of the devices.
The FDA asks that written comments be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with this docket number: FDA-2008-N-0488.
Or you may visit www.regulations.gov and submit comments there.
Government Agencies To Study Quality of Life After LASIK
SILVER SPRING, Md., November 2009 The LASIK Quality of Life Project is a new joint study by the U.S. Food and Drug Administration (FDA), National Eye Institute and U.S. Department of Defense to determine the percentage of LASIK patients who have significant problems that affect their quality of life after the procedure. The study also aims to discover predictors of such problems.
In Phase 1, which began in July, a Web-based questionnaire was created to assess patient-reported LASIK results and evaluate associated quality-of-life issues.
Phase 2 will study quality of life and post-LASIK satisfaction as reported by active-duty personnel at the Navy Refractive Surgery Center.
And Phase 3, to end in 2012, will study these issues in the general population.
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If any negative results are related to the safety or effectiveness of LASIK lasers, the FDA will decide whether action is needed.
"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health, in a news release.
Flexivue Micro-Lens for Presbyopia Debuts
AMSTERDAM, November 2009 This fall, Presbia Cooperatief U.A. unveiled an implantable micro-lens for treatment of presbyopia called the Flexivue System.
The Flexivue lens is 3mm in diameter and is implanted in the corneal stroma.
In a 10-minute procedure, a laser creates a pocket in the cornea, where the lens is placed with a special device created by Presbia. The pocket seals itself, and the lens can stay in place permanently or can be removed if the patient becomes more presbyopic and needs a stronger prescription.
The implantation is done only in the non-dominant eye, for closeup viewing, with the dominant eye used for distance vision.
The FDA has not approved this treatment, but the company plans to begin clinical trials in several European countries this quarter.
Large Study Compares Laser-Created LASIK Flaps
with Blade-Created Flaps
BARCELONA, Spain, September 2009 People with low to moderate myopia and astigmatism whose LASIK flaps were created with a laser had faster visual recovery and better uncorrected visual acuity than those whose LASIK flap was created with a microkeratome.
The laser group had a higher percentage of eyes that reached 20/20 or better vision (92.4 percent vs 90.0 percent), as well as a higher percentage that reached 20/16 or better. The laser group also experienced a lower rate of complications and enhancements.
The retrospective study involved 42,143 eyes, all of which had received wavefront-guided LASIK with a VISX S4 IR Advanced CustomVue excimer laser.
The flap creation comparison was between the IntraLase FS60 femtosecond laser (Abbott Medical Optics) and the Moria Evo3 One-Use Plus microkeratome.
Steven Schallhorn, MD, reported on the study at the meeting of the European Society of Cataract and Refractive Surgeons in Barcelona.
Noninvasive IntraCor Procedure Corrects Near Vision
Without Cutting Through the Eye's Surface
BARCELONA, Spain, September 2009 One way of overcoming presbyopia is to correct the nondominant eye for near vision and leave the dominant eye alone for distance vision. This is called monovision.
IntraCor (Technolas Perfect Vision GmbH, Munich, Germany) is a new approach to monovision surgery that uses a femtosecond laser called the Femtec to make tiny cuts in concentric circles under the surface of the central part of the cornea of one eye. This steepens the central cornea to provide better closeup vision.
The procedure is designed to change the cornea beneath its surface, in the stroma, without making a flap as would be done in LASIK.
During a year-long study of 25 presbyopia patients who had IntraCor surgery, the patients gained an average of 4.5 lines of visual acuity on an eye chart, and the results were stable.
According to Technolas, the procedure is fast, safe and minimally invasive, with a short treatment time and fast recovery.
IntraCor is not yet FDA-approved for use in the United States. Mike P. Holzer, MD, reported on the study at the meeting of the European Society of Cataract and Refractive Surgeons in Barcelona.
Four-Year Follow-Up of Collamer Lens Implantation Finds
Procedure Safe and Effective
KANAGAWA, Japan, August 2009 An implantable lens made of a biocompatible collagen copolymer may be an option for people with moderate to high nearsightedness.
Called the Visian Implantable Collamer Lens (Staar Surgical), the lens may be an alternative for people who shouldn't have LASIK because they have severe myopia or thin corneas. To check its safety, effectiveness, predictability and long-term complications, researchers at the University of Kitasato School of Medicine examined 56 eyes of 34 people who underwent implantation. The evaluations occurred at specific intervals during a four-year period.
Four years after the surgery, 79 percent of the eyes were within 0.5 diopter of the targeted correction, and 93 percent were within one diopter. The scientists found no vision-threatening complications, but noted that observation for a longer period is necessary, in case of later complications.
The study was reported in Archives of Ophthalmology in July.
In Study, Wavefront-Guided LASIK Yields Good Results But
With Higher-Order Aberrations
WATERLOO, Ontario, Canada, July 2009 A study of 324 eyes of 162 wavefront LASIK patients showed that wavefront-guided LASIK provides excellent visual acuity and contrast sensitivity, according to the study authors.
- 136 eyes (84 percent) had visual acuity of 20/20 or better.
- 131 eyes (80.9 percent) were within half a diopter of the correction goal.
- Statistically significant improvements occurred in contrast sensitivity.
The researchers, from the School of Optometry at University of Waterloo in Ontario, also noted statistically significant increases in all types of higher order aberrations except for spherical.
The study report appeared in Journal of Refractive Surgery and was supported by Alcon Laboratories Inc. and the Canadian Optometric Education Trust Fund.
As More Drug-Resistant Bacteria Develop, Researchers Evaluate Risk to Refractive Surgery Patients
SEOUL, Korea, June 2009 Infections are rare in LASIK and other refractive surgery, but a study has found that infection rates are slowly rising. The trend seems to be part of the larger trend of infections from coagulase-negative staphylococci (CNS) and methicillin-resistant staphylococcus aureus (MRSA) in communities worldwide.
Researcher Kyoung Yul Seo, MD, and colleagues evaluated infection risk in 105 patients by taking swab samples from the surface of their eyes before they had refractive surgery. CNS appeared in 84.9 percent of the cultures grown from the samples; 31.4 percent was methicillin-resistant. In other studies during the past 10 years, resistant CNS appeared in fewer than than 2 percent of samples.
The researchers used five fluroquinolone antibiotics to treat the bacteria, but it was the one most recently approved by the FDA that was most effective. Dr. Seo's opinion was that using newer drugs as initial treatment may limit the ability of these bacteria to produce resistant mutations.
"Since resistant CNS is now widespread, it makes sense to develop ophthalmic agents using the newest fluroquinolones and to consider their use after refractive surgery to attempt to reduce infections," said Dr. Seo in a news release. The research was based at Yonsei University College of Medicine in Seoul.
New Company Hopes To Produce Laser Procedures for Presbyopia
MUNICH, Germany, May 2009 A new joint venture between Bausch + Lomb and 20/10 Perfect Vision AG will focus on laser-based treatments for presbyopia, the eye condition that makes it difficult for just about everyone to read or do close work after age 40.
The new company, Technolas Perfect Vision, will work on procedures such as IntraCOR, which stands for intrastromal correction of presbyopia. IntraCOR uses a femtosecond laser to remove tissue in the main part of the cornea (the stroma), without cutting the cornea or its outer layer (epithelium). According to researchers, this method maintains the structural integrity of the cornea, has a low infection rate and promotes wound healing.
IntraCOR researcher Mike P. Holzer, MD, outlined the procedure in Cataract & Refractive Surgery Today Europe in January. The report says that IntraCOR takes about 20 seconds, during which gas bubbles form in the cornea. Vision is blurry for two or three hours, but when the gas bubbles dissolve, the cornea is clear again, distance vision returns and near vision has improved. Near vision improves even more for most people by the next day.
IntraCOR isn't FDA-approved yet, but it has the European CE Mark for treatment of presbyopic hyperopes. Studies are underway for a wider range of uses.
Study Says That for High Nearsightedness, LASIK Has Limited Predictability
HELSINKI, Finland, March 2009 Forty-seven LASIK patients who started with 9 diopters or more of myopia were examined at one, three, six and 12 months, and between two and five years after surgery. (The surgeries took place from 1999 to 2003.)
- Forty percent of eyes attained vision within one diopter of the intended goal.
- Seventy percent were within two diopters.
- Ninety-one percent were within three diopters.
Over time, most of the eyes regressed mildly but significantly toward myopia during the two-to-five-year period.
The researchers concluded that LASIK is safe and moderately stable, but for people with high myopia (-9.00 to -17.00 diopters), its predictability is limited.
Still, all the patients but one said they were very satisfied and would have chosen LASIK again.
The study was reported in the February issue of Journal of Refractive Surgery.
PresbyLASIK Frees Many People From Bifocals
McHENRY, Ill., March 2009 An investigational laser vision correction procedure known as PresbyLASIK freed most middle-aged people from the need to wear bifocals or reading glasses during one clinical trial.
About 99 percent of more than 100 PresbyLASIK patients (average age 53) had little or no need for eyeglasses after a six year follow-up, said Robert L. Epstein, MD, director of Mercy Center for Corrective Eye Surgery.
PresbyLASIK is being investigated as a way to solve vision problems of people who develop presbyopia beginning at around age 40, when near vision typically begins to blur. Bifocals, progressive lenses or reading glasses usually are needed to correct presbyopia.
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[Page updated January 2011]
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