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The key to KeraVision Inc.'s Intacs implants: If the patient doesn't like the result or suffers a side effect such as glare, doctors can remove the ring with a good chance of returning the patient's eye to its condition before surgery.
"People who know about the ring can't be talked into having the laser" surgery, said David Schanzlin of the University of California, San Diego, who led KeraVision's clinical trials.
"It's the idea that if this doesn't work, you can take it out."
Advisers to the Food and Drug Administration voted unanimously yesterday that the implants - two crescents about the thickness of a contact lens that form a ring around the cornea's edge - should be sold.
But the panel stressed that Intacs can cause side effects. Removing the implant will often, but not always, relieve the problem.
"It's largely reversible," said panel chair Dr. James McCulley of the University of Texas Southwestern Medical Center. But he stressed, "It's not an absolute certainty."
The FDA is not bound by its advisers' recommendations but typically follows them.
Nearsightedness occurs when a person's cornea, the membrane covering the front of the eye, is too steeply curved. Flattening the cornea can help correct nearsightedness. Hundreds of thousands of Americans have sought radial keratotomy, where surgeons slice the cornea with a knife, or laser surgery that shaves the cornea to do that.
But those surgeries can be risky, sometimes causing problems with night vision, glare, seeing halos or blurry vision. Patients occasionally cannot see as well after surgery as before. Thus, most patients who choose these operations do so only because they are severely nearsighted.
With Intacs, the implants' slight weight flattens the cornea without the permanence of cutting the tissue.
KeraVision hopes to attract some 20 million mildly to moderately nearsighted Americans - those whose vision ranges from 20/40, where it's OK to drive but a movie is blurry without glasses, to 20/200, where patients can barely see the big "E" atop eye charts.
In a yearlong study of the surgery on 449 eyes, 97 percent could see 20/40 or better without glasses or contact lenses after the implant. About 74 percent had 20/20 or better vision without glasses, and 53 percent could see 20/16 - the sharper vision Schanzlin said is required of combat pilots.
Most patients achieved good vision a day after surgery.
Intacs isn't risk-free: Some 7 percent to 17 percent of patients suffered side effects similar to laser surgery, including glare, halos and problems with night vision.
About 5 percent of patients had their implants removed. That included 14 patients dissatisfied with their vision correction and 16 who had visual side effects. Removing the implant corrected over 80 percent of those side effects, the company said.
The operation itself is "very easy to master," said Schanzlin.
Patients get anesthetic eye drops to numb the eye, but remain awake. The doctor clamps the eyelid open, cuts a tiny pocket into the cornea and uses a special device to slip the crescents onto the cornea. The implants are made of the same material as the lenses implanted into cataract surgery patients. A single stitch closes the wound.
It takes about 15 minutes. About 15 percent of patients report some pain; as with any surgery, infection also is a risk.
The procedure will cost about $2,200 an eye, about the same as laser surgery - and includes removal if the patient is not satisfied, KeraVision said.
The FDA is reviewing three sizes of Intacs. The company is testing thicker versions for more severely nearsighted patients.
Yesterday, a prosecutor told a jury the case is no whodunit. Kimberly Hricko went on trial on charges of murdering her husband, Stephen, during what was supposed to be a romantic Valentine's weekend getaway.
She stood to collect on a $200,000 life insurance policy and had talked about killing her husband to end their dull marriage, prosecutor Robert Dean said in opening statements.
"There is nothing more that Kimberly Hricko wanted than to get rid of her husband," Dean said.
The defense says the evidence is inconclusive, and Hricko was depressed and a suicide risk.
The young couple had been having marital troubles and went on a Valentine's Day weekend getaway featuring a campy "Mafia Wedding" whodunit on-stage in which the groom sips poisoned champagne and drops dead during a toast and the audience tries to solve the mystery.
Hours later, in the early morning of Feb. 15, Stephen Hricko, a 35-year-old golf course superintendent, was found dead.
Kimberly Hricko, 33, told police that after they returned to their room, her husband began drinking heavily and tried to pressure her into having sex. She said she left to drive to a friend's home in Easton but got lost. When she returned, around 1 a.m., she saw smoke and went to the front desk for help. A hotel guest and a worker broke into the cottage and dragged out Hricko's body.
The fire, which appeared to have started on or near the bed, had burned out, but Hricko was dead.
One cigar was missing from a new pack. Kimberly Hricko told investigators that her husband smoked when he drank. However, family and friends told police that Hricko did not drink or smoke.
An autopsy found that Hricko had no carbon monoxide in his blood and no soot or burns in his trachea or lungs, suggesting he had stopped breathing before the fire started.
The report said Hricko probably died of poisoning, but didn't say what poison or how it got into his body.
Prosecutors said the Hrickos' marriage was in trouble. The couple, who were raising a daughter, now 9, had been attending counseling sessions. According to court documents, Kimberly Hricko had asked her husband for a divorce, but he refused.
Kimberly Hricko, a surgical technician, had offered a co-worker $50,000 to arrange his murder in early 1998 and weeks later confided to a friend that she had been planning to give her husband a drug that would paralyze him, Dean said. She was "progressively digging herself into a hole of violence," he said.
Defense attorney Harry Trainor suggested Hricko was seriously depressed and could have been at risk of suicide. He also said Hricko worked with toxic pesticides, which may have contributed to his death.
"No medical doctor, pathologist or toxicologist can reliably tell us the cause of Stephen Hricko's death," Trainor said.
The trial is expected to last a week.
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Preval's announcement late Monday aimed to break a 19-month stalemate that has left Haiti without a budget or a functioning government and halted the flow of aid to this impoverished Caribbean nation. But it also ignited fears that Haiti's fledging democracy has failed, leaving the country on the road to dictatorship once again.
The motive for the shooting yesterday afternoon in Bois Verna, near downtown Port-au-Prince, wasn't immediately known, and there were no arrests.
Two gunmen on a motorcycle opened fire at a vehicle carrying Marie-Claude Calvin, wounding her and killing her driver. She was shot in the neck, chest and leg, but her injuries weren't life-threatening, said Dr. Bernard Leveque of University Hospital, where Calvin was being treated. Earlier, doctors said they would operate on Calvin.
Preval visited his sister at the hospital, as did former President Jean-Bertrand Aristide.
Calvin worked at the National Palace as a personal secretary in charge of correspondence for her brother, the president, but she wasn't known as a leading political figure in Haiti. Her husband, Serge, is an executive committee member of the Lavalas Family political party founded by Aristide.
The president's declaration dealt a blow to Haiti's flagging experiment with democracy. Haiti has suffered four military coups since 1986, when a popular uprising brought an end to the Duvalier family's 29-year dictatorship.
Monday was the original end-of-term date for the legislature, dominated by foes of Preval and his mentor, former President Jean-Bertrand Aristide. Preval says lawmakers' recent vote to extend the term indefinitely until unscheduled elections in the future had no legal validity.
''I have neither the authority to prolong their terms nor to dissolve Parliament,'' Preval said.
Parliament had failed to ratify four Preval choices for premier, and Preval said Monday that once his latest nominee - Education Minister Jacques-Edouard Alexis - names a Cabinet, he will decree it the new government.
''Preval has staged a coup against our democratic institutions,'' Senate President Edgard Leblanc told The Associated Press after Preval's address.
''Preval has become a dictator,'' added Rep. Arry Marsan, also from the majority Struggling People's Organization party.
Haiti has not had an effective government since June 1997, when Premier Rosny Smarth resigned to protest elections allegedly rigged with Preval's complicity to favor Aristide loyalists.
Now Haiti, which shares the island of Hispaniola with the Dominican Republic, appears destined for another bout of uncertainty.
The U.S. State Department was not pleased with Preval's announcement, noting with ''regret'' the further gaps between Preval and the legislature.
''We hope with continuing good faith and effort by the parties concerned, a resolution will be found,'' it said Tuesday in a statement.
Disgruntled legislators, even more unpopular than Preval, appear unable to muster much protest from ordinary Haitians, who are struggling simply to deal with their own grinding poverty.
''The lawmakers brought this down upon their own heads. They don't represent the people's aspirations,'' said artist Mathieu Painvier.
Like many Haitians, Painvier still believes in the charismatic Aristide.
In 1994, President Clinton sent 20,000 U.S. soldiers to Haiti to restore Aristide to power after three years of repressive military-backed rule. But Aristide, who has already begun his re-election campaign for the 2000 presidential election, now stands accused of shady machinations.
Alexis' Cabinet is likely to be dominated by Aristide loyalists. And Aristide's Lavalas Family party, founded before he handed over power to his handpicked successor in February 1996, probably will sweep elections - if the sides ever agree on how to hold a vote.
''Preval has executed the anti-democratic plan that he and Aristide have been preparing for a long time,'' Marsan, the lawmaker, declared.
Others agreed with that assessment.
''A totalitarian government is just around the corner,'' said Haitian Chamber of Commerce president Olivier Nadal.
The decision is not sudden, the prime minister insists. And it has nothing to do with his battle to win re-election May 17, he says.
But Israeli opposition leaders and political commentators said yesterday that Netanyahu's recent reversals - supporting legislation to provide free nursery school for 3-year-olds, for instance, and rejecting a proposal to cut benefits to senior citizens - are blatant election-year economics.
And they're crying foul, charging that Netanyahu, who acts as his own finance minister, is trying to buy votes.
"He is changing his policy totally from positions that he took only two or three months ago," said senior Labor Party legislator Avraham Shohat, who served as finance minister under the previous, Labor Party-led government.
"The cost is going to be billions of shekels to the state, only because he wants to be elected again."
The subject was the topic of the day yesterday for many Israeli radio talk shows, with callers hotly debating the merits of candidates trying to pour money into an election-year economy. But not many appeared to believe that the promised benefits will actually materialize.
"Who can object when the government wants to help the weak parts of society?" asked a caller who gave his name as Yaakov. "But in another six months, the prime minister - whoever he will be - will inevitably cancel all these decisions and the sweet taste will be replaced by a bitter one."
The controversy is the latest storm in an election campaign that is shaping up as nasty even by Israeli politics' rambunctious traditions.
Political newcomer Amnon Lipkin-Shahak, who has announced plans to run for prime minister at the head of a new centrist movement, was met last week with tossed fruit - and a chicken leg - during a maiden campaign outing to a Tel Aviv outdoor market and Netanyahu stronghold. The day before, the former general had castigated Netanyahu as a "danger to Israel." Several of the vendors have since apologized.
And almost daily, the major-party candidates, Netanyahu and Labor's Ehud Barak, or their aides question one another's integrity and assert that the other party, if elected, will be weaker in dealings with the Palestinians, the central issue of this and other Israeli campaigns.
But Netanyahu's challengers are also likely to focus sharply on economic and social issues, areas in which the prime minister is considered vulnerable. Israel's economy is lackluster, with a growth rate in 1998 of less than 2 percent, inflation about 9 percent and unemployment relatively high at between 9 percent and 10 percent.
Last week, Netanyahu announced that he planned to raise the government's inflation target, from a tightly restricted figure of 4 percent to between 5 percent and 7 percent. And yesterday, he insisted that he has long planned to relax spending controls at this point in his term, even though neither the measure for children or that to help senior citizens was included in his recent 1999 budget proposal. The budget, now several weeks overdue, is expected to come before parliament next week.
"I said, 'First the brakes (on spending) and then the growth,' " the prime minister told Israel Radio, in defense of his policy to relax the restrictions. And he said his government, which has managed to cut the budget deficit it inherited from the previous administration, can now do something "good for the country, for investment in infrastructure and for our future."
01-13-99
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