Eye-Opening Help for the Nearsighted
One patient entered surgery after 30 years of Coke-bottle glasses and contacts, then walked to the Inner Harbor here wearing nothing on her eyes but a look of delight. Another who used to hold books inches from her face could suddenly read a clock perched high on the wall.
Four decades after contact lenses burst onto the scene, patients in a nationwide clinical trial are now wearing soft, synthetic lenses inside their eyes. There, the implants remain permanent fixtures.
If the devices pass rigorous safety tests, they could further revolutionize the field of vision-correction surgery that up to now has been dominated by lasers. Dr. Sheri Rowen, a Baltimore ophthalmologist participating in the trial, said the implants offer an important option to patients who are too nearsighted to benefit from laser surgery.
“This is something that covers the high end of nearsightedness that is very difficult to be covered by laser surgery,” said Rowen, one of 10 ophthalmologists in the trial. “It’s also something for people who want instant vision correction and don’t want any downtime, any time off work not seeing.”
Speaking with enthusiasm that can border on the promotional, Rowen said she is amazed by the transformations she has seen in patients.
“It’s the biggest ‘wow’ factor I’ve seen yet, and I’ve seen some incredible things,” said Rowen, who also performs laser surgery.
Although she acknowledges that the procedure is experimental, she predicts that the devices will prove safe and satisfy skeptics who worry about side effects that could result from years of use.
The big question is whether the implant, sandwiched in the tight confines of the eye, can avoid rubbing and inflaming the tissues around it.
“Ophthalmologists are worried about taking a normal eye and putting a device inside it,” said Dr. Terrence P. O’Brien, a refractive surgeon at the Johns Hopkins Wilmer Eye Institute. “Potentially, these could be put in young people and remain there for 50 years or more. These devices have to be considered for their long-term side effects.”
O’Brien said he is concerned the devices could cause cataracts or glaucoma, serious eye diseases that could result if lenses even subtly abrade the eye’s natural structures. Rowen said the lenses remain buffered by fluid and are made of a material that is compatible with living tissues.
The clinical trial is being sponsored by Staar Surgical, a California company that markets implantable lenses used in cataract surgery. It is seeking approval from the Food and Drug Administration for lenses that would be given to people who are severely nearsighted but have otherwise healthy eyes.
Nobody seems to dispute that the lenses correct vision to a remarkable degree--restoring 20-20 vision to people who would be hard pressed to count fingers held at arm’s length. Patients, especially, seem overjoyed by the results.
“Before, if I was holding a printed page in front of me, I’d have to put it four inches from my eye in order to read,” said Angela Simmons, a 37-year-old Towson, Md., woman who has been wearing contact lenses for 20 years. “When Dr. Rowen was finished, I could read the clock on the wall.”
The operation is done under topical anesthesia in less than 10 minutes.
Using a fat syringe, the surgeon injects the lens through a tiny incision on the edge of the iris, the pigmented portion of the eye. The lens is folded like a taco shell when it enters the eye, but springs open once it comes to rest.
It sits behind the iris and in front of the eye’s natural lens. There, it helps the lens bend incoming light into a sharp image, something the eye cannot do on its own. The lenses are not meant to be treatments for chronic eye diseases, such as macular degeneration or glaucoma.
Rowen charges $1,500 to $1,800 per eye for the procedure, but says the price is likely to rise if the devices receive FDA approval. For now, under terms of the clinical trial, patients can receive an implant in one eye only. Later, they can return to have the job completed.
Implantable lenses have been used for several years in Europe and South America, where medical devices are not as rigorously scrutinized as they are in the United States.
Until the 1990s, nobody imagined that anything but glasses or contact lenses could repair vision blurred by simple nearsightedness, a condition that occurs when the eye is too long from front to back. A surgical procedure called radial keratotomy changed all that, correcting vision with a series of tiny cuts.
More recently, laser surgery has taken over the market. Lasers shorten the eye with a beam of energy that shaves a small amount of tissue from the cornea. This year, an estimated 500,000 people in the United States alone will have laser surgery, O’Brien said.
The technique has FDA approval for the correction of nearsightedness and astigmatism, a condition in which the front surface of the eye is not truly spherical. For the nearsighted, lasers can bring a considerable degree of correction--but not as much as lenses.
“I think there will probably be a place for the lens implant,” said Dr. Gerri Goodman, research director at the Greater Baltimore Medical Center’s laser vision center. “If a patient is out of the range of the laser and we can give another safe, effective surgery, the implant will offer a lot of hope.
“That’s where the lenses should be used now--for people who have no other options,” Goodman said.
In the hotly competitive field of refractive surgery, that might not be the end. Rowen said she sees the day when the lenses will be offered to the farsighted and to the moderately nearsighted.
Even if they are limited to the Coke-bottle crowd, Rowen is convinced the lenses will find a robust market.
“When people get up in the morning, they want to see the clock. They want to see where they are in the middle of the night when they get up,” she said. “That’s why we’re interested in restoring vision for people.”