FDA Approves Eye Implant – Best Option For Aging Baby Boomers?

A new ocular implant, called raindrop Implant was recently approved by the Food and Drug Administration US .. promises eye implant to help aging eyes focus on fine print and nearby objects.

What does the implant raindrop Do?

The raindrop Implant is inserted into the cornea (the transparent surface, front) of an eye. It is designed specifically to help people with presbyopia, which is an age-related decline in the ability to focus his eyes.

You know how some people have to hold the menu at arm’s length to read it? That’s the problem with this type of ocular implant is trying to solve.

FDA approval is considered important because as the population ages in the baby boom, there has been an increase in the need for corrective medical devices. The FDA has approved the device specifically for men and women between the ages of 41 and 65 who have had cataract surgery and have trouble clearly focus on nearby objects and fine print and require reading glasses 1.50 2.50 diopters of power – however, do not wear contact lenses or require glasses for distance vision.

is like a contact lens

The ocular implant is similar to a contact lens appearance – but much smaller. In fact, it is smaller than the eye of a needle. It is 32 micrometers thick and 2 mm in diameter.

will have to undergo a surgical procedure to receive the implant. During the procedure, an optical surgeon cutting a flap in the cornea of ​​the non-dominant eye using a laser (called femtosecond laser flap).

The surgeon then slides the implant into the opening and turn the cap in place -. Similar to how laser eye surgery works

The device itself is called Raindrop Near Vision Inlay. It is the second corneal implant device that has been approved by the FDA to correct farsightedness in people who have undergone cataract surgery.

How Raindrop Implant Work?

The implant Raindrop Near Vision Inlay works by changing the shape of the cornea. Is increasingly vision.

Manufacturers lenses described as a “hydrogel embedding microscopic”. Reshapes the cornea in an elongated shape -. Which is again similar to how laser eye surgery works

As you probably know, the FDA does not approve any medical device unless there is significant clinical evidence that it works as advertised. In the case of the raindrop, the FDA approved the device after it went through a clinical trial with over 300 patients.

In this trial, patients were monitored for two years after receiving the implant. Two years after undergoing surgery, 92% of patients had 20/40 vision or better at distances close to the implant.

There are side effects?

As can be expected when a lens on the cornea of ​​the eye becomes, there are some side effects and some risk of complications.

In its announcement of approval for the device, explained the FDA that the implant can cause problems with glare or halos -. Especially those who already suffer from these issues

There is also a risk of complications during and after surgery. Some patients may develop infections and other complications of the cornea, for example, including corneal scarring, swelling, inflammation, clouds, thinning, or fusion.

Patients who experience these complications can submit them to a second surgery to remove scale or replace.

Who makes the raindrops Vision near inlay?

The drop of water is made by a company based in California called ReVision Optics, Inc.

revision Optics, Inc. (RVO) is a private company based in Lake Forest, California You can view the contact information of the company here: http://ift.tt/29ourPm

the company created raindrop Near vision corneal inlay “fed by the belief that no one should have to keep a menu out under market conditions, “he explains his About page.

Revision holds patents for raindrop in the United States, Europe, Canada, Japan and Australia.

You can read more about the FDA approval for the implant eye drop of water in the announcement of the original press here .

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