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FDA Approves Eye Implant to Combat Presbyopia

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FDA Approves Eye Implant to Combat Presbyopia
The KAMRA™ Inlay may be the next best eye surgery since LASIK, but it’s not right for everyone with declining near vision. In April 2015, the FDA (Food and Drug Administration) announced the approval of this implantation device that’s designed to “improve near vision in certain patients with presbyopia” (1).

The KAMRA™ Inlay manufactured by AcuFocus Inc. is implanted on the cornea of one eye. The cornea is the clear front surface of the pupil. The KAMRA is the first of its kind that will be implanted to correct the “near vision in patients who have not had cataract surgery”.

As the body ages, the “ability to change the focusing power of the eye” often diminishes or is lost in adults between the ages of 40-50. The KAMRA is designed for patients 45 to 60 years old. It corrects presbyopia, a natural aging process.

The device is ring-shaped and has an opaque appearance. It blocks the unfocused light rays that enter the eye and improves the near vision. The “peripheral light rays” are blocked and the “central light rays” are allow to move through a small center opening located in the device. This process makes near objects and small print clearer.

An eye surgeon implants the device by cutting a “pocket in the cornea of one eye of the patient” and then inserting the device inside the pocket. The device has “8,400 microscopic openings surround the central aperture to allow oxygen and nutrients to flow freely and naturally through the eye.”




Who Is a Good Candidate for KAMRA Implant?

Patients who haven’t had cataract surgery may be eligible for the implant. They must also have the ability to “focus clearly on near objects or small print and need reading glasses with +1.00 to +2.50 diopters of power, but do not need glasses or contacts for clear distance vision.”

This is why the device gives improved near vision for the implanted eye and doesn’t interfere with the distance vision since both eyes continue to work together.

William Maisel, M.D., deputy center director for science in the FDA’s Center for Devices and Radiological Health said, “The KAMRA inlay provides a new option for correcting near vision in certain patients” (1).

There are many people who won’t be good candidates for this new implant device. For example, if you’ve had cataract surgery or are suffering from various eye conditions, the implant isn’t safe for you to use.

“Severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease” are all conditions that prevent the implantation of the KAMRA.

The introduction of the implant into an eye with any of these conditions could make the condition worse or create other problems with the eyes and vision. Some of those could be night vision difficulty, glare, halos and blurry vision.

reading glasses

Possible Side Effects

Some of the possible side-effects could also be cornea issues caused by such complications resulting in clouding, swelling, thinning or perforation of the cornea.

The solution to such complications is the removal of the implant, but this doesn’t guarantee that the patient’s vision will return to normal. There could be permanent damage.

What if you’ve had LASIK or some other type of “refractive procedures” are you eligible for the implant? The FDA warning label on the device states that the effectiveness and safety for LASIK patients is “unknown”.

The FDA review of clinical studies revealed the 83.5% of the 478 patients evaluated had improved vision of 20/40 or even better 12 months after their surgery.

20/40 is the average level of vision needed for near vision tasks of reading magazines and newspapers.

According to AcuFocus, “The KAMRA inlay procedure may not eliminate the need for reading glasses.” The non-surgical alternatives are glasses or contact lens.

References & Image Credits:
(1) FDA
(2) AcuFocus

Originally published on TopSecretWriters.com

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