Corneal laser surgery may be a sight for sore eyes for people suffering from nearsightedness or those just tired of wearing glasses, but experts warn that people considering the increasingly popular operation need to be well-informed about the procedure and its possible results before going under the laser.

Advertising promising "You will no longer need to wear glasses or contact lenses," "You will have better eyesight in just 30 seconds," "The procedure is definitely reliable" is guaranteed to catch the eye of people with severe myopia and who see the laser surgery as the only viable option, or those whose eyesight may not be very bad but who no longer want to wear glasses or bother with contact lenses.

The procedure may seem even more simple because of the celebrities who have undergone it, including the U.S. golf giant Tiger Woods, whose myopia was cured by corneal refractive laser surgery.

The number of people undergoing laser eye surgery has drastically increased not only in the United States, but also in Japan. There are no statistics for the number of operations performed in Japan, but according to the Japan Ophthalmologists Association, it was believed to be around 10,000 in 1999 alone.

It is doubtful, however, whether all the patients who underwent the surgery were given completely accurate information, including details about possible unwanted side effects.

The surgery involves changing the shape of the cornea to correct myopia, hyperopia (farsightedness) and astigmatism. Currently, there are two major methods -- photorefractive keratectomy (PRK) and laser assisted in-situ keratomileusis (LASIK). Both procedures use a laser beam to remove a small amount of the cornea to reshape it to improve focus and both take less than 10 minutes per eye.

In PRK, which was developed in the mid-1980s, the laser beam is applied directly to the eye so the surface layer of the cornea is also removed, which causes some pain after the operation.

LASIK, which has been in use for about 10 years, differs from PRK in that its procedure involves a surgical blade by which only the surface of the cornea is cut into the shape of a hinged flap and then the laser is applied to the inner tissue of the cornea.

Up until a few years ago, PRK was the most common procedure, but now LASIK is overtaking it in popularity as it has proved to cause less postoperative discomfort and allows vision to recover quicker, according to experts.

Fees for the operation usually run to between 200,000 yen and 250,000 yen per eye for PRK and 250,000 yen to 400,000 yen per eye for LASIK, depending on the clinic as well as individual eye conditions.

The surgery is not covered by national health insurance. Asked why, an official of the health ministry said its safety as well as its effectiveness have yet to be proven.

Laser's limited use

The medical instrument using the excimer laser was approved by the health ministry in January 2000, but only for use in PRK because clinical tests necessary for government approval have only been completed for that procedure.

Nevertheless, the popularity of LASIK is surging and most publications on the procedure include a number of success stories that make it appear as if the 10-minute surgery is every myopia sufferer's dream come true.

"LASIK is a wonderful procedure," said Noriyuki Shimada, an engineer who works in Tokyo and a satisfied LASIK patient, expressing his joy at how good his right eye has become.

He had the surgery in August 2000, and the vision in his right eye started showing dramatic improvement only two days after the operation, he said.

After more than a year, Shimada still enjoys good vision and has had no problems so far.

But many ophthalmologists warn that people should be aware of all the possible negative aspects -- complications and side effects -- of PRK and LASIK.

Despite continual improvements in the technology, laser surgery cannot guarantee 100 percent visual recovery for everyone and there are even cases in which the surgery goes wrong and a patient's vision irreversibly worsens beyond the point where it can be corrected by glasses or contact lenses.

Shimada, who is satisfied with the LASIK performed on his right eye, has suffered "haze," or turbidness, in his left eye, which underwent PRK twice, in 1999 and 2000, at a well-known doctor's clinic.

He had the second PRK on the left eye after the first operation caused the haze. But the second procedure did not improve the problem.

After having difficulty with haze in his left eye and severe myopia in his right eye, he decided to subject the right eye to LASIK by another doctor.

He filed a lawsuit against the first doctor with the Tokyo District Court in 2001 for what he claims was the doctor's negligence in the unsuccessful surgery.

Shimada claims he did not give the first doctor informed consent, because the doctor failed to thoroughly explain the possible problems and risks associated with the procedure.

"I'm not doing this (suit) for the money I paid, but to prevent others from being victims," because many other people have been unable to do anything but remain silent, Shimada claimed.

Although statistics are not available, it is believed that reports of complications and side effects involving both PRK and LASIK are increasing.

Many victims of failed operations do not protest because of a waiver doctors have them sign prior to the surgery, Shimada said.

Usually such documents, including in Shimada's case, state all the possible complications and risks, including the haze.

The documents also state that patients must follow the doctor's instructions in the event of complications. According to the doctor named in the suit, who asked not to be identified, Shimada failed to do so, worsening his condition.

The doctor, who claimed to have gone over all the possible risks and complications with Shimada prior to the surgery, believes the haze in Shimada's eye will go away in the near future.

"Assessing whether the operation was successful depends heavily on the patient's subjective view," he said, adding that many patients are still coming to him.

But Shimada said, "Those doctors only emphasize the advantages, while discounting the risks" in order to have the patient sign the waiver.

He added that the document provides doctors with protection to hide their mistakes and avoid responsibility.

Qualifications not needed

Tatsuo Yamaguchi, head of the ophthalmology department at St. Luke's International Hospital in Tokyo's Chuo Ward, expressed concern that doctors who are not recognized by the Japanese Ophthalmological Society, a group of researchers, are performing the procedures improperly.

The society has drawn up guidelines for laser surgery that have been revised three times to keep up with technological advances.

Its third set of guidelines, revised several months ago, spells out the contraindications and applicable conditions of patients for PRK and LASIK.

It also says that doctors who conduct the surgery should preferably be those who have been certified by the group as ophthalmologists. Certified doctors have to undergo the group's evaluation process every five years to renew their certificates, according to the society.

The guideline, however, is nonbinding and not accredited by the health ministry, even though it was the ministry that asked the society to draw it up.

"When we conduct the surgery, we have to be ready to deal with worst-case scenarios, but doctors without the certificates are not that responsible," Yamaguchi said.

He said a number of doctors, regardless of whether they are ophthalmologists or specialists in other areas, have performed laser operations without sufficient knowledge because the procedure appears lucrative.

"In Japan, once you get a doctor's license after passing a national exam, you can practice in any field of medicine," Yamaguchi said, adding that as a result, it is not against the Medical Practitioners Law for a doctor who has no training in ophthalmology to conduct laser eye surgery.

An excimer laser device costs between 30 million yen and 70 million yen and requires maintenance of about 5 million yen annually, he said.

"Therefore, doctors want as many patients as possible to recover their investment and to make a profit," Yamaguchi said.

Certification questionable

However, other experts point out that the certificate issued by the Japanese Ophthalmological Society has nothing to do with a doctor's skill in LASIK as the organization's exam does not cover the eye surgery.

Officials of the Medical Draft Kinshi Eye Clinic, based in Minato Ward, Tokyo, say it is necessary to make sure doctors perform the surgery only after receiving sufficient training.

Toru Yahagi, an expert ophthalmologist and the president of the clinic, said all doctors practicing at the clinic first went through training under him for more than a year.

"I do not think such a training system has been set up at other clinics," Yahagi said, expressing concern over the safety of patients treated by inexperienced doctors.

Since laser eye surgery is still in the development stage and lacking a long-term followup report, opinions among doctors differ. No wonder patients are never sure what is true and whom to believe.

Nevertheless, Yamaguchi and Yahagi share the view that informed consent from patients is a must.

"I always hand my patients a document that states all the possible disadvantages and risks associated with the surgery, and tell them to think about it at least twice at home before making a decision," Yamaguchi said.

Yamaguchi believes most patients come to him without knowing much about the surgery because information available from the media usually focuses only on the bright side of the procedure.

He said such patients usually have excessive expectations about the surgery and they can often be dissatisfied when their eyesight does not recover as they had hoped.

Patients should think carefully about why they believe they need the surgery and whether they really can no longer live with glasses or contact lenses, he said.

The Medical Draft Kinshi Eye Clinic, where 15,534 laser surgeries were performed as of December, holds an orientation session to thoroughly explain the surgical procedures to people who are considering the option, in which participants can ask Yahagi questions.

"If people are uncertain about the possible risks, they definitely should not have the surgery," Yahagi said.