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FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance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Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.  

“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 The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed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The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format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 In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the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

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.

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fitness

Mejore su salud caminando

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(Family Features) Una caminata no solo es buena para el cuerpo, sino también para el alma. La actividad física, como caminar, es una de las mejores formas de reducir el estrés y mejorar su estado de ánimo. Sin embargo, los informes revelan que las tasas de caminatas están disminuyendo constantemente en los Estados Unidos.

En promedio, uno de cada cuatro adultos estadounidenses permanece sentado durante más de ocho horas al día, según la investigación de los Centros para el Control y la Prevención de Enfermedades (CDC). Esto puede tener consecuencias negativas para la salud física y mental. El ejercicio regular mejora el estado de ánimo, aumenta la energía e incluso puede ayudarle a dormir mejor. Estar activo es una de las mejores maneras de mantener la mente y el cuerpo sanos.

Tome esta recomendación de la American Heart Association (la Asociación Americana del Corazón), que ha trabajado durante décadas para promover políticas y estrategias que faciliten que las comunidades estén y se mantengan activas. Un ejemplo es el Día Nacional para Caminar, que lo estableció la organización para incentivar a las personas a moverse más a lo largo del día. para que puedan pensar, dormir, vivir y sentirse mejor.

De hecho, moverse más puede beneficiar a su cuerpo y a su mente de numerosas maneras, como por ejemplo las siguientes:

Reducir el riesgo de sufrir enfermedades. Realizar la cantidad recomendada de actividad física (al menos 150 minutos de actividad moderada, 75 minutos de actividad intensa o una combinación de esas actividades por semana) está relacionado con un menor riesgo de sufrir enfermedades, tener huesos y músculos más fuertes, una mejor salud mental y función cognitiva, y menor riesgo de depresión, según el Departamento de Salud y Servicios Humanos de los EE. UU.

Estar más al sol. El ejercicio al aire libre es un manera fácil de mantenerse en movimiento y estar al sol, lo que puede mejorar el estado de ánimo, aumentar la inmunidad y ayudarle a obtener un poco de vitamina D. Pasar tiempo al aire libre es una opción que no tiene costo y se ha demostrado que reduce el estrés, promueve el sentido de pertenencia y mejora el estado de ánimo.

Mejorar la función cognitiva y mental. La actividad física mantiene la mente alerta ahora y en el futuro. Los estudios muestran que niveles más altos de condición física están relacionados con una mejor atención, aprendizaje, memoria de trabajo y resolución de problemas. Es más, un estudio publicado en el “British Journal of Sports Medicine” demuestra que las personas que realizan la cantidad recomendada de actividad física tienen menos probabilidades de desarrollar depresión.

Vivir una vida más larga. La esperanza de vida saludable puede verse afectada positivamente por el aumento de la actividad. Según una investigación publicada en el “American Journal of Epidemiology”, cambiar solo 30 minutos de estar sentado por actividad física de baja intensidad reducía el riesgo de muerte en un 17 %.

Manténgase en movimiento para reducir el estrés y mejorar su salud. Amplía la información en heart.org/movemore.

Inspírese para mantenerse en movimiento

Un poco de creatividad puede ser de gran ayuda para que su caminata sea más divertida. Es posible que piense que caminar es una actividad en solitario, pero hacerlo con compañía la hace aún más placentera. Pida a compañeros de trabajo, amigos o familiares que le acompañen.

Una caminata es una excusa perfecta para tomar un descanso después de un largo día sentado en el escritorio. Si trabaja de forma remota, realice una conferencia telefónica mientras se mueve o considere que la caminata es su recompensa por completar un proyecto.

Utilice su caminata como una oportunidad para escuchar un nuevo audiolibro sin culpa o cree una lista de reproducción con su música favorita para salir a caminar.

Experimente con recorridos alternativas. Intente tomar nuevas rutas para hacer sus caminatas más interesantes. Esto también le ayuda a evitar que se aburra si va por el mismo camino de siempre.

Si hay algo más que puede incentivarle a mantenerse en movimiento es sin dudas una mascota. Su mascota puede ayudarle a ponerse en forma. Quienes tienen un perro tienen más probabilidades de alcanzar sus objetivos de acondicionamiento físico respecto de aquellos que no lo tienen. De hecho, según el “Journal of Physical Activity & Health”, las personas que tienen perros tienen un 34 % más de probabilidades de caminar 150 minutos a la semana respecto de quienes no tienen un perro. Las mascotas también pueden ayudar a reducir el estrés, la presión arterial, el colesterol y el azúcar en sangre y a aumentar su felicidad y bienestar general.

Fotos cortesía de Shutterstock


SOURCE:
American Heart Association

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laundry and cleaning

Go Green with Home Cleaners

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(Family Features) If you’re among those looking for ways to clean your home while also going green, it may be easier than you think.

Consider these easy and affordable solutions to help you live more environmentally friendly. You may be surprised to find you already have many of these household products on hand.

Baking soda: A natural, safe, effective and gentle solution, baking soda can serve multiple home cleaning needs. Make a paste of three parts baking soda to one part water. Rub onto silver with a clean cloth or sponge. Rinse thoroughly and dry for shining serving or decor pieces. Additionally, you can sprinkle baking soda on upholstery and carpet to get rid of odors.

Vinegar: With the acidity to help get rid of dirt and grime around the home, vinegar can be used to clean cloudy glassware. Simply soak paper towels or a cloth in full-strength white distilled vinegar and wrap around both the inside and outside of the glass. Let sit before rinsing clean. To remove lime deposits on your tea kettle, add 1/2 cup distilled white vinegar to the water and let it sit overnight. In the morning, boil the vinegar for a few minutes then rinse with water.

Lemons: With a fresh, natural smell, lemons have the acidity to remove soap scum, clean and shine brass and remove hard water deposits. Just spray some lemon juice on tile surfaces to remove soap scum or hard water deposits. Squeeze lemon juice on a cloth and use to polish brass around the home.

Houseplants: Plants serve as natural air purifiers. African violets and ferns are beautiful ways to help clear the air.

Other easy, green ideas for keeping your home clean include opening windows and doors while you clean to improve air quality and taking off your shoes when you come inside, which can help avoid tracking dust, dirt, pollen and more throughout the house.

Visit eLivingtoday.com for more eco-friendly advice.

Photo courtesy of Unsplash


SOURCE:
eLivingtoday.com

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Health

Take a Rest from Stress

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5 strategies to combat stressful triggers

(Family Features) Stress, the physical or mental response to external causes like overwhelming work assignments or difficult life moments, can add unnecessary pressure to your day to day. While everyone feels stress from time to time, when left untreated or unrecognized, it can begin to wreak havoc in the form of anxiety.

In honor of National Stress Awareness Month, consider these strategies to combat stress from the National Institutes of Mental Health.

Learn Your Triggers
Different events and situations cause stress for different people. Knowing what triggers your stress to kick in – mounds of office paperwork, important financial decisions or hectic mornings, for example – can help you plan and prepare for stress-inducing moments.

Exercise and Eat Right
Maintaining physical health can be beneficial for mental health, too. Find time to do exercises you enjoy like walking, jogging, yoga or playing a sport. Identifying activities that bring you joy can make it easier to fit 30-60-minute workouts into your schedule without adding even more stress. Complement your workout routine with nutritional meals that help you stay on track with your fitness goals.

Practice Relaxation
Whether you find inner peace through journaling, breathing exercises, reading or some other form of slowing down, find what works for you and prioritize fitting it into your daily schedule. Relaxing activities help you slow down the pace of life, providing a chance to reset by doing something you enjoy.

Get Enough Sleep
A lack of quality sleep can add to stress. Creating a bedtime routine can increase your sleep habits and help you achieve the expert-recommended 7-9 hours per night. Put away electronics, which can interfere with your ability to calm your mind, and find an activity that puts you at ease like reading a book or listening to relaxing music. Ensure your bedroom is optimized for comfort by making it cool, dark and quiet.

Create a Network of Support
Everyone experiences stress. Reach out to family members and close friends you can lean on in stressful and frustrating moments. Share your feelings and encourage others to do the same, which can increase trust and help everyone in your circle cope in a positive way.

Find more ways to combat stress and care for your mental health at eLivingtoday.com.

Photo courtesy of Unsplash


SOURCE:
eLivingtoday.com

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