September 2, 2002.
By HILARY WALDMAN,
The Record (Bergon County, NJ).
About this time last year, Kristina Metcalfe was looking to adopt a guide dog and was preparing for a life of blindness.
But a doctor in Boston and a little-known contact lens allowed the 28-year-old West Hartford, Conn., woman to change her plans radically.
Instead of a guide dog, she adopted a rambunctious terrier from the pound and moved from the security of her parents' house into a condominium of her own. Metcalfe's vision is so good now that she can drive.
"It had gotten to the point where I could not cross the street," recalled Metcalfe, who makes custom picture frames at her family's shop. "I was standing at the end of the driveway, and I could not see the cars. I could only sense the motion." The story of the doctor and his lens has an almost biblical ring. For appropriate patients - those with certain kinds of damage or injury to the cornea - the lens allows the blind to see.
And although Dr. Perry Rosenthal, who developed the lens, introduces himself as a lifelong agnostic, his crusade to make his invention available has a level of religious fervor.
He wants to reach each of the 30,000 to 50,000 people in the United States alone whom he thinks could regain their sight with the lenses.
"There's a saying in the Talmud," says Rosenthal, quoting the ancient book of Jewish law: "To save a life is to save the world."
But Rosenthal, a 68-year-old pioneer in the field of conventional contact lenses, is getting frustrated. Today, eight years after his Boston Scleral Lens for corneal damage won FDA approval, fewer than 400 people in the United States are using it.
Insurance companies have refused to cover the $5,500 cost. Few eye doctors refer patients to Rosenthal's clinic, and academic medical centers nationwide have been reluctant to adopt his technology and make it available outside of his suburban Boston location.
"We're the only ones fitting these in the United States," said Rosenthal, assistant clinical professor of ophthalmology at Harvard Medical School. "They should be standing in line."
Rosenthal said he hopes a new computer-assisted lathe recently installed at his clinic will allow him to produce lenses more quickly and inexpensively. He hopes the new lathe will allow him to treat more patients and perhaps persuade eye specialists elsewhere in the country to fit the lenses. The $200,000 lathe was subsidized by Bausch and Lomb.
Because most of his patients have been functionally blind for years and thus largely unable to work, Rosenthal subsidizes the care of 60 percent of his patients. He says he loses money on every patient he fits but still would like more.
Rosenthal's first invention was far more commercially successful. In the early 1970s, he and colleagues began experimenting with plastic polymers that allowed the cornea to breathe.
The cornea is the body's only organ that takes oxygen from the air, not from the blood. The earliest solid plastic contact lenses could suffocate the cornea and damage the eye.
The work led to the development of the gas-permeable contact lens, a lens still worn by 4 million people in the United States. Bausch and Lomb bought the technology in 1983, and Rosenthal's Boston Lens and lens-care solutions remain the most widely used hard contact lenses in the country.
But conventional contact lenses do not work for people with damaged corneas, the clear windows of tissue that cover the front of the eyes, much like the lens of a camera.
Part of the cornea's job is to control the entry of light into the eye. If the cornea's surface is not perfectly smooth and clear, the light will not enter the retina properly, and vision will be distorted or, in the worst cases, erased.
With the advent of breathable rigid plastic, it became theoretically possible to smooth out a damaged cornea with a contact lens and restore sight. Soft contact lenses are of no value to people with corneal damage because they conform to the distorted shape of the eye.
But if the corneal surface is not smooth, even a rigid lens will not rest properly. And with certain conditions, the cornea is so sensitive that even the touch of wind and sunlight cause incredible pain. A piece of plastic would be unbearable.
Rosenthal thought back to the first contact lenses, huge blown-glass cups made in Germany in the 1890s. The early lens, which was about the size of an eyeball, hollowed out and cut in half, rested on the sclera, the white of the eye, not the cornea in the center.
Combining his new breathable plastic and the ancient German design, Rosenthal made the first breathable contact lens for cornea disease patients in 1986. But as with the first conventional contact lens, the initial promise was followed by years of frustration and disappointment.
He tinkered with the corneal lens for the next 12 years, improving the success rate from 30 percent early in the process to the current 80 percent of people fitted with the lens who are able to see well.
Still, the scleral lens is not for everybody. Every year, 45,000 people with corneal damage have transplant operations. But Rosenthal says the lens could allow almost 7,000 people - 15 percent of those who now get transplants - to avoid surgery. It also can help people who are not candidates for replacement corneas.
The lens is most helpful for people with conditions in which the eye itself is so dry or blistered that replacement corneas would just be damaged again. There are also conditions in which the cornea becomes scarred or distorted that cannot be treated by transplant.
Kristina Metcalfe's trouble began when she was a toddler. She lost much of the vision in her left eye after an accident seemed to exacerbate an existing problem with her cornea. Her eyes were always dry, a shortage of natural tears allowing her blinking eyelids to erode her corneas.
By April 2001, the cornea of her right eye was literally wearing away. The only way to save her one good eye was to slather it with ointment and cover it with a patch.
But even while she kept both eyes patched all day and all night, her vision continued to fail. Her doctor at the Massachusetts Eye and Ear Infirmary, an affiliate of Harvard Medical School, referred her to Rosenthal.
Like most of Rosenthal's patients, Metcalfe is still waiting to see if her health insurance will pay the bill. Meanwhile, her care is being covered by the Boston Foundation for Sight, a non-profit organization established by Rosenthal to raise money and the visibility of the scleral lens.
Dr. Janine Smith, deputy clinical director of the National Eye Institute at the National Institutes of Health in Bethesda, Md., said she had not even heard of the lens until one of her patients brought her a newspaper article about it.
She said corneal disease is not among the leading causes of blindness in the United States, but there is a group of patients who could benefit from the lens. "I don't think they're a panacea," Smith said of the lenses.
But doctors who have referred patients to Rosenthal cannot understand why the lens is not more widely accepted.
"It's absurd; it's ridiculous," said Dr. Ernest Kornmehl, a Boston ophthalmologist who has referred patients to Rosenthal. "It's really a fabulous thing."
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