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FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

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Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.  

women s black mascara. LASIK surgery,
Photo by Pixabay on Pexels.com

“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”  

LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye. LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses. 

The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information. In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the procedure. To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure. It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed. 

The FDA collaborated with external experts on research efforts that informed the recommendations in the draft guidance. The agency, in collaboration with the National Eye Institute and the Department of Defense, conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS)External Link Disclaimer, questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.  

By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling recommendations from patients, health care providers and stakeholders. The FDA will continue to monitor the latest scientific data related to LASIK and work with professional medical societies and patient advocacy groups to help ensure that risk information about LASIK devices is disseminated to patients, as new information becomes available. 
 

Related Information

Source: FDA

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  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts

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The Importance of Regular Immunizations for Heart Health

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 immunizations

(Family Features) While most parents are good at keeping track of vaccines their kids need to stay healthy, many adults don’t realize there are immunizations important for keeping themselves heart-healthy, as well.

Adults, especially those with a history of heart disease or stroke, should take steps to stay up-to-date on preventive vaccines, particularly for the flu and COVID-19.

Influenza – While many experience just a few days of aches and chills, the flu can be deadly for some, including young children, the elderly and those with chronic conditions like heart disease, stroke and diabetes. There has also been research linking flu infection to cardiovascular disease (CVD). Getting a flu shot can not only prevent the flu, it may also reduce the risk of having a heart attack or stroke.

In fact, a study published in “Stroke” found that, among a group of people hospitalized for various reasons, those who experienced a flu-like illness within a month of their hospitalization were 38% more likely to have a stroke. Receiving the flu vaccine within a year prior to hospitalization lowered a person’s stroke risk to 11%.

“Getting an annual flu shot should be part of routine health care for all individuals, especially for people who are already living with chronic health conditions that put them at higher risk for heart attacks or strokes,” said Eduardo Sanchez, M.D., M.P.H., FAHA, American Heart Association chief medical officer for prevention. “The potentially serious complications of the flu are far greater for those with chronic diseases. This is true not just for older people but even those age 50 and younger who have a history of high blood pressure, heart disease or diabetes.”

COVID-19 – At the onset of the pandemic, the American Heart Association established the COVID-19 Cardiovascular Disease Registry, which found people with or at risk for CVD were more likely to become infected with and die from COVID-19. Additionally, the research found many people experience heart and vascular disease after getting COVID-19.

A study from the registry published in “Circulation: Arrhythmia and Electrophysiology” found new-onset atrial fibrillation in 1 in 20 patients hospitalized with COVID-19. Additionally, research also found people hospitalized with COVID-19 had a higher risk of stroke compared with people who had similar infectious conditions such as influenza or sepsis.

“We can’t stress enough the connections between COVID-19 and cardiovascular disease,” Sanchez said. “There is clear evidence that people who have heart and vascular disease and even those with CVD risk factors are more likely to get COVID and to have more severe complications from the virus.”

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Other Immunizations – While flu and COVID-19 vaccines are of the utmost importance, there are a number of other immunizations that can help keep people heart-healthy.

  • The pneumococcal vaccination protects against a common cause of severe pneumonia and is especially important for people 65 and older, and others with certain underlying medical conditions. This type of pneumonia can be deadly, especially for people already at high risk for health complications, including CVD. One shot is usually good for several years, although you may need a second one later depending on your age at your first shot.
  • Shingles, a viral infection caused by the chickenpox virus, has been linked to an increased risk of stroke. More than 99% of people age 40 or older in the United States may carry the dormant chickenpox virus, also known as the varicella-zoster virus, and not even realize it.

Learn more about important immunizations and find other preventive health tips at heart.org.

Photo courtesy of Getty Images

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SOURCE:
American Heart Association

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts


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Lifestyle

Get chronic UTIs? Future treatments may add more bacteria to your bladder to beat back harmful microbes

Researchers developed a biomaterial releasing beneficial E. coli to combat urinary tract infections by outcompeting harmful bacteria, aiming to reduce antibiotic resistance and manage chronic UTIs effectively.

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bacteria
Certain strains of E. coli can outcompete disease-causing microbes for resources. NIAID/Flickr, CC BY-SA

Sarguru Subash, Texas A&M University

Millions of people in the U.S. and around the world suffer from urinary tract infections every year. Some groups are especially prone to chronic UTIs, including women, older adults and some veterans.

These infections are typically treated with antibiotics, but overusing these drugs can make the microbes they target become resistant and reduce the medicines’ effectiveness.

To solve this problem of chronic UTIs and antibiotic resistance, we combined our expertise in microbiology and engineering to create a living material that houses a specific strain of beneficial E. coli. Our research shows that the “good” bacteria released from this biomaterial can compete with “bad” bacteria for nutrients and win, dramatically reducing the number of disease-causing microbes.

With further development, we believe this technique could help manage recurring UTIs that do not respond to antibiotics.

Bringing bacteria to the bladder

For the microbes living in people, nutrients are limited their presence varies between different parts of the body. Bacteria have to compete with other microbes and the host to acquire essential nutrients. By taking up available nutrients, beneficial bacteria can stop or slow the growth of harmful bacteria. When harmful bacteria are starved of important nutrients, they aren’t able to reach high enough numbers to cause disease.

Delivering beneficial bacteria to the bladder to prevent UTIs in challenging, though. For one, these helpful bacteria can naturally colonize only in people who are unable to fully empty their bladder, a condition called urinary retention. Even among these patients, how long these bacteria can colonize their bladders varies widely.

Current methods to deliver bacteria to the bladder are invasive and require repeated catheter insertion. Even when bacteria are successfully released into the bladder, urine will flush out these microbes because they cannot stick to the bladder wall.

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Micrograph of clusters of pink rods scattered across a blue textured wall, while yellow blobs extend thin tendrils across the clumps
This microscopy image shows the bladder of a mouse (blue) covered with E. coli (pink) and the white blood cells (yellow) attacking them. Valerie O’Brien, Matthew Joens, Scott J. Hultgren, James A.J. Fitzpatrick, Washington University, St. Louis/NIH via Flickr, CC BY-NC

Biomaterials to treat UTIs

Since beneficial bacteria cannot attach to and survive in the bladder for long, we developed a biomaterial that could slowly release bacteria in the bladder over time.

Our biomaterial is composed of living E. coli embedded in a matrix structure made of gel. It resembles a piece of jelly about 500 times smaller than a drop of water and can release bacteria for up to two weeks in the bladder. By delivering the bacteria via biomaterial, we overcome the need for the bacteria to attach to the bladder to persist in the organ.

We tested our biomaterial by placing it in human urine in petri dishes and exposing it to bacterial pathogens that cause UTIs. Our results showed that when mixed in a 50:50 ratio, the E. coli outcompeted the UTI-causing bacteria by increasing to around 85% of the total population. When we added more E. coli than UTI-causing bacteria, which is what we envision for future development and testing, the proportion of E. coli increased to over 99% of the population, essentially wiping out the UTI-causing bacteria. Moreoever, the biomaterial continued releasing E. coli for up to two weeks in human urine.

Our findings suggest that E.coli could stick around and survive in the bladder for extended periods of time and successfully decrease the growth of many types of bacteria that cause UTIs.

Person pressing hands against stomach. bacteria
UTIs can be painful. Images we create and what actually happens are always beautiful when we have imagination/iStock via Getty Images Plus

Improving biomaterials

Our findings show that E. coli can not only control harmful bacteria it’s closely related to but also a broad range of disease-causing bacteria in humans and animals. This means scientists might not need to identify different types of beneficial bacteria to control each pathogen – and there are many – that can cause a UTI.

Our team is currently evaluating how effectively our biomaterial can cure UTIs in mice. We are also working to identify the specific nutrients that beneficial and harmful bacteria compete over and what factors may help beneficial bacteria win. We could add these nutrients to our biomaterial to be released or withheld.

This research is still at an early stage, and clinical uses are not in development yet, so if it does reach patients it will be well in the future. We hope that our technology could be refined and applied to control other bacterial infections and some cancers caused by bacteria.

Sarguru Subash, Assistant Professor of Veterinary Pathobiology, Texas A&M University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.


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Lifestyle

Does Your Favorite Brand of Dark Chocolate Contain Dangerous Metals?

According to a recent article from Consumer Reports, there are some brands of Dark Chocolate that contain dangerous levels of lead, and cadmium. 

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Consumer Reports found dangerous heavy metals in dark chocolate from popular brands.

Dark Chocolate

According to a recent article from Consumer Reports, there are some brands of Dark Chocolate that contain dangerous levels of lead, and cadmium. 

Dark Chocolate has become popular due to studies suggesting that they are rich in antioxidants,  which is beneficial to the heart, and it having low sugar properties that positively impact health. 

grey metal on soil. dark chocolate
Photo by Pixabay on Pexels.com

The article, which was posted in mid December, states that 28 popular brands were tested, and that 23 of them contained high levels of the dangerous metals. 

For more details, check out the article from Consumer Reports: https://www.consumerreports.org/health/food-safety/lead-and-cadmium-in-dark-chocolate-a8480295550/

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

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  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts

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