The Food and Drug Adminis-tration announced the launch of a collaborative study with the National Eye Institute and the Department of Defense to examine the potential impact on quality of life from LASIK.
The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality-of-life problems after LASIK surgery and identify predictors of these problems.
Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web-based questionnaire to assess patient-reported outcomes and evaluate quality-of-life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.
Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active-duty population treated at the
Phase 3 will be a national, multicenter clinical trial and will study the impact of the procedure on quality of life in the general population. Patient enrollment in Phases 2 and 3 has yet to begin but plans are under way. Phase 3 is expected to end in 2012.
The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.
"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.
The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.
Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.
The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.
"Many people in the
NeoVista Phase II, 24-Month Data Released
NeoVista released 24-month data from its Phase II study designed to examine the company's novel epimacular brachytherapy procedure used in conjunction with bevacizumab anti-VEGF therapy for the treatment of neovascular age-related macular degeneration. The long-term data from the study showed that a majority of patients maintained their visual acuity and at least 20 percent also experienced a marked improvement in vision at month 24. The data also showed that 76 percent of the patients only needed two protocol-required injections of Avastin throughout the 24-month period.
In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers a focused dose of energy directly to the choroidal neovascular lesion without damaging the adjacent healthy retinal vasculature. Utilizing strontium 90, the focused energy is delivered to a target area up to 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVista's epimacular device is less than that from a typical chest X-ray.
The ongoing multicenter feasibility study enrolled 34 trial participants (with a mean age of 72 years) from June 2006 to April 2007 at two centers in
These patients, with predominantly classic, minimally classic or occult (with no classic) choroidal neovascularization received a single exposure of epimacular brachytherapy in combination with two intravitreal injections of Avastin, one dose prior to or at the time of radiation delivery and another one month later, depending on which arm of the trial the patient was enrolled in. Additional therapy was delivered based upon the investigator's evaluation of disease activity.
There was an expected increase in the incidence (50 percent) of cataract formation related to the vitrectomy, performed when administering epimacular brachytherapy. Comparative data was examined to look at outcomes of patients who entered the study with their natural lens versus those who had already undergone cataract surgery. This analysis showed that 80 percent of patients who had cataract surgery prior to study entry maintained their visual acuity and 30 percent gained significant vision at 24 months.
When comparing to the cohort of patients who entered the study with their natural lens, 65 percent percent of patients maintained their visual acuity and 20 percent percent had significant vision gain, highlighting the fact that cataract formation played a role in long-term visual acuity data.
There were a limited number of adverse events in the trial which were related to the vitrectomy procedure (retinal tear, retinal detachment, subretinal hemorrhage and vitreous hemorrhage), rather than the epimacular brachytherapy. To date, no instances of radiation toxicity have been reported with many patients followed for as long as three years.
NeoVista has recently completed enrollment in the company's first pivotal trial, CABERNET (CNV Secondary to AMD Treated with Beta Radiation Epiretinal Therapy). CABERNET is a multicenter, randomized, controlled study that has enrolled 450 subjects at 45 sites worldwide, and is evaluating the safety and efficacy of NeoVista's therapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis (ranibizumab) versus Lucentis alone.
Do Eyes Reveal Alzheimer's?
University of California, Irvine, neuroscien-tists report that retinas in mice genetically altered to have Alzheimer's undergo changes similar to those that occur in the brain—most notably the accumulation of amyloid plaque lesions.
In addition, the scientists discovered that when Alz-heimer's therapies are tested in such mice, retinal changes that result might predict how the treatments will work in humans better than changes in mouse brain tissue.
These findings are key to developing retinal imaging technology that may help diagnose and treat people with Alzheimer's, which afflicts 5.3 million people in the
For a study appearing in the November issue of the American Journal of Pathology, Zhiqun Tan, a UCI neuroscientist leading the research, and colleagues analyzed the retinas of Alzheimer's mice that had been treated with immunotherapy. Vaccinated mice performed better on learning and memory tests than untreated mice, and their brains had fewer plaque lesions. Similarly, retinas in the treated mice had fewer lesions than in untreated mice. However, the treated mice's retinas had worse inflammation and vascular changes associated with Alzheimer's than did their brains.
When immunotherapy was tested in humans, inflammation of brain tissue occurred similar to that observed in the mice retinas. "This tells us the retina may be more sensitive at reflecting changes in the human brain," Dr. Tan says.
