In late February, Gov. Steven L. Beshear of Kentucky signed Senate Bill 110 into law, allowing Kentucky optometrists to perform certain injections and laser procedures and remove chalazion and lesions.

Specifically, the law allows optometrists to do the following:
  • Use the most up-to-date, cost-effective methods of administering medication, such as medicated contact lenses or periodic injections rather than daily medications. 
  • Remove lumps and bumps from the eye and eyelids. 
  • Perform laser procedures, including laser trabeculoplasty, peripheral iridotomy, iridoplasty, capsulotomy, YAG capsulotomies and LASEK. Optometrists will not be performing cataract extraction, retinal surgery, LASIK, PRK or other procedures that require general anesthesia. 
Additionally, the Kentucky Board of Optometric Examiners now has sole authority to determine what constitutes the practice of optometry, which means that the board could single-handedly expand optometric scope of practice.

“This provision gives the optometry board the authority to determine all future optometric scope of practice authority,” says Richard L. Abbott, MD, an ophthalmologist from the University of California at San Francisco, and president of the American Academy of Ophthalmology. “This provision removes legislative/administrative oversight of the Board of Optometry. Thus, a board that does not have any medical or osteopath members, no medical/osteopath surgeons, now has the sole authority to determine the standards that will enable an optometrist to perform surgical procedures in Kentucky. It eliminates the national standard of care that citizens across the United States are now assured. In Kentucky, as well as Oklahoma, this bill has now created two levels or standards of surgical care. A citizen traveling on business/vacation from another state can no longer be assured that the quality of care the individual receives in Kentucky will be on the same level of care as the individual would have received at home,” says Dr. Abbott.

Proponents of SB 110, also called the Better Access to Quality Eye Care Act, say the bill was designed to improve access to quality eye care for rural Kentucky residents. While optometrists are located in 106 of Kentucky’s 120 counties, two-thirds of the state’s counties do not have an ophthalmologist.

“This legislation will result in better access to quality eye care,” says I. Ben Gaddie, OD, FAAO, who is president-elect of the Kentucky Optometric Association. “It will also mean more convenience for patients and their family members who drive or accompany them to appointments. Many patients must travel at least an hour to reach an ophthalmologist—something no one with vision problems or the elderly should be forced to do.

“To be treated for some conditions currently, patients must make a second appointment to travel to another doctor, many times in another town, despite their local eye doctor having the education and training to provide the treatment. This extra step can result in additional time off work and an extra co-payment for the patient. It also increases costs to taxpayers because Medicaid patients must see a second doctor and charge transportation costs to the state when they travel to another county for eye care.”

According to Dr. Gaddie, optometrists will now be allowed to treat the conditions they currently manage using the most efficient and safest procedures to make sure they maintain their position as the primary eye-care provider. “Optometrists have worked for decades in concert with ophthalmologists in the pre- and post-surgical care of patients, including the identification and monitoring of surgical and laser complications. Now, they will be able to fully use their training to the benefit of their patients,” he says.

LensAR System Cleared for Capsulotomy and Fragmentation  
LensAR announced that it has received 510(k) clearance from the Food and Drug Administration for the use of the LensAR Laser System for anterior capsulotomy and lens fragmentation during cataract surgery. FDA clearance was granted on March 16, 2011.
 The company says its LensAR Laser System has been developed to meet the advancing needs of refractive cataract surgeons and their patients. The proprietary 3D-CSI (Confocal Structured Illumination) imaging and biometry system is being designed to image and analyze the anatomy across all grades of cataract to improve proficiency. LensAR says the 3D-CSI provides clean, low-noise images that are both high-contrast and high-resolution from the anterior surface of the cornea to the posterior capsule. The precision of the LensAR Laser System creates an exact capsulotomy incision size and placement based on IOL selection and fragments high-grade cataracts for easier removal.
The LensAR Laser System is cleared by the FDA for anterior capsulotomy and lens fragmentation. The system has been used in more than 500 eyes outside the United States to date. For other indications it is an investigational device limited by U.S. law to investigational use only.
He notes that increasing access to care is crucial. “In order to keep up with Kentucky’s population needs, the University of Kentucky’s Institute of Medicine projected that the need for eye doctors would increase up to 81 percent in less than 10 years,” he explains.

Dr. Abbott counters that the law puts patients at risk. “In the final analysis, the surgical eye care of the citizens of the commonwealth is placed at unnecessary risk,” he says. “For example, a patient in Kentucky now goes to an eye-care provider, thinking that the eye surgery that he or she has been scheduled to undergo will be performed by a surgeon, only to learn that the person performing the surgery has never been to medical school, has never completed a one-year hospital internship, and has never completed a three-year surgical residency. And to add insult to injury, the person who is performing this surgical procedure is not required to tell the patient these facts. I think it’s pretty obvious that patient quality of surgical care is at risk.”

Dr. Abbott notes that successful treatment begins with a correct diagnosis. “From the patient’s correct diagnosis, the surgeon may determine that an alternative treatment plan is justified, that surgery may be too risky as a result of analyzing the patient’s medical history, or that the surgical procedure must be modified as a result of the patient’s existing medical history,” he says. “Thus, surgery is not just the technical skill, but the judgment to determine when and if a surgical procedure is justified in the first place. And, once a procedure is undertaken, a critical part of the postoperative care is how the surgeon responds to any complications. Surgical proficiency and appropriate judgment are acquired through years of medical education and clinical training.”

This is not the first time that optometrists in Kentucky have asked legislators to expand their scope of practice. “Before 2011, Kentucky optometrists have asked legislators to modernize laws that govern the practice of optometry three times in the past 30 years. Each time, optometrists have acted safely and responsibly. That’s a 30-year track record of safety and accountability,” Dr. Gaddie adds.

Lucentis Study Meets Endpoint

Genentech/Roche announced that one of two Phase III studies evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema met its primary endpoint. The study, known as RISE, showed that a significantly higher per-centage of patients receiving monthly Lucentis achieved an improvement in vision of at least 15 letters on the eye chart at 24 months, compared to those in a control group, who received a placebo (sham) injection. A preliminary analysis of the data did not reveal any unexpected safety signals and further analyses are ongoing. Topline results from the RISE study were presented at the 34th Annual Macula Society Meeting in March.

“DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition,” said Hal Barron, MD, chief medical officer and head of global product development. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”

Lucentis was recently approved for treatment of visual impairment due to DME in Europe, where it is marketed by Novartis. In the United States, Lucentis was approved for treatment of neovascular age-related macular degeneration in 2006 and more recently for treatment of macular edema following retinal vein occlusion in June 2010. RISE and RIDE are two identical, parallel confirmatory studies designed to support application to the U.S. Food & Drug Administration for a potential new indication for Lucentis for DME.

RISE is a multicenter, randomized, double-masked, sham injection-controlled, 36-month Phase III study designed to assess the safety and efficacy profile of Lucentis in 377 patients with DME. The primary endpoint compared the proportion of Lucentis and sham-treated patients who gained at least 15 letters in BCVA at month 24, relative to baseline. Patients were randomized to receive monthly injections of either 0.3-mg Lucentis (n=125), 0.5 mg Lucentis (n=125), or monthly sham injections (n=127). The study was not designed to compare the two doses of Lucentis, but each dose against the control group.

At three months, rescue laser treatment was made available to all patients, if needed based on pre-specified criteria. Laser treatment is the current standard of care for DME.

Secondary endpoints included other measures of visual acuity, need for laser treatments and changes in retinal anatomy. After month 24, patients in the control group are eligible to receive monthly injections of 0.5-mg Lucentis and all patients will continue to be followed for 36 months.

Colder Temperature May Increase Dry Eye
A study published in Investigative Ophthalmology & Visual Science suggests that a temperature less than 30 degrees Celsius on the eye and eyelid could be the cause for the onset or worsening of dry eye.

The study, (Meibomian Lipid Films and the Impact of Temperature), showed that the cold temperature causes the meibum to become too thick and stiff to spread onto the eye surface.

“In outdoor conditions, the wind accelerates the drop in temperature of the ocular surface and the eyelids, thus the effect is even more pronounced,” says author Igor A. Butovich, PhD, assistant professor in the department of ophthalmology and Graduate School of Biomedical Sciences at the University of Texas Southwestern Medical Center. “This mechanism seems to be one of the major factors that cause dry eye to worsen in cold, windy weather such that it can affect even healthy people.”

Based on previous experience, the research team expected to see measurable effects of temperature on meibum. However, the researchers were surprised the results of their experiment found that a bulk of meibum abruptly melted in a very narrow range of temperatures, right around an eye surface and eyelid temperature of 32 to 34 degrees C. If the temperature fell just a few degrees below that, the bulk meibum solidified, which could then result in plugging up the meibomian gland ducts.

The experiments further demonstrated that even if the thicker, stiffer substance does reach the eye surface, it may not spread as easily as under normal conditions. The tear film will not have the right characteristics, which might cause it to evaporate more quickly and decrease its protective capabilities.

Dr. Butovich underscores that the goal is to maintain the quality of the tear film as close to normal as possible, under all conditions. “In cold climate, anything that keeps eyes and eyelids warm should help meibum flow easier, and form and maintain a better tear film; in windy conditions, protection from the wind—for example, with eye goggles—should reduce the tear film evaporation,” he says.

The authors strongly suggest that temperature be tightly controlled in future studies, especially since over-the-counter and prescription eye lubricant formulations that are being tested are most likely temperature-dependent. “Our experiments provided strong evidence that even a small drop in the ocular surface and eyelid temperatures is critical,” says Dr. Butovich. “It would be logical to use this information and our approaches while designing new eye drop formulations.”

More Data on Omega 3s & Retinal Health
Past research has shown that omega-3 fatty acids may help prevent human blindness, but a new study in mice reveals exactly how that works.

Omega-3 fatty acids are fats commonly found in fish oil. Several years ago researchers at Children’s Hospital Boston determined that the fatty acids helped to prevent retinopathy. That same team conducted this follow up study.

For the study researchers fed mice a diet high in omega-3 fatty acids, and found it prevented abnormal blood vessel growth in the retina.The researchers also found the benefits of omega-3s are not affected by drugs such as aspirin or other painkillers. This is good news for diabetics who take aspirin to prevent heart disease.

“The ability to prevent these neovascular eye diseases with omega-3 fatty acids could provide tremendous cost savings, said Lois Smith, MD, PhD, senior investigator on the study. “The cost of omega-3 supplementation is about $10 a month, versus up to $4,000 a month for anti-VEGF therapy,“ she said, referring to drugs such as Macugen and Lucentis used in AMD and diabetic retinopathy. “Our new findings give us new information on how omega-3s work that makes them an even more promising option.”

The fatty acids also activated proteins that improve insulin sensitivity. Those proteins are the same ones targeted by type 2 diabetes drugs. This means omega 3s could also be used to improve insulin sensitivity in people with diabetes or pre-diabetes. The study appeared in Science Translational Medicine, February 14, 2011.

RVO Patients Have Greater
Incidence of Stoke

The incidence of cardiovascular and cerebrovascular events in patients with retinal vein occlusion was sig-nificantly greater than of patients without RVO in a large, U.S. popula-tion-based, retrospective review of a health-care claims database. The incidence of stroke in RVO patients was nearly double that of non-RVO controls. The report appeared in the March Archives of Ophthalmology.

RVO and control patients were matched for age and sex; events of myocardial infarction, cerebrovascular accident or stroke were identified for patients with and without RVO. Of 4,500 patients with RVO and 13,500 controls, the event rates for myocardial infarction were 0.87 per 100 person-years and 0.67 per 100 person-years, respectively. The adjusted rate ratio for MI was 1.03 for RVO vs. controls. Event rates for stoke were 1.16 and 0.52 per 100 person-years for RVO and controls, respectively. The adjusted rate ratio for CVA was 1.72 for RVO vs. controls.