ABLEnews Extra

              "Neither Safe Nor Effective"
          
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Columbia, MO--An article published in today's Journal of the American
Medical Association reports that surgery that had been used as a
possible treatment for a blinding eye condition could instead be
harmful to a patient's vision.
   
As a result, clinical trials on the treatment have been halted,
according to officials at the M.U. School of Medicine.
   
Nationally, 250 people participated in the study that produced the
findings. The University of Missouri-Columbia's Mason Institute of
Ophthalmology took part in the study and screened more than 30 people.
One person qualified for enrollment in the "no surgery" group.
   
Nonarteritic ischemic optic neuropathy, or NAION, is a condition that
results from the painless swelling of the optic disc, where the retina
and optic nerve meet. It is the leading nerve-related cause of sudden
vision loss in elderly people and it affects 6,000 people annually.
   
Lenworth Johnson, M.U. associate professor of ophthalmology and
neurology, said that NAION is a silent, opportunistic, blinding
disease because there is no pain. Loss of vision usually occurs during
sleep, he said.
   
Launched in 1992 and funded by the National Eye Institute, the
Ischemic Optic Neuropathy Decompression Trial was to study the safety
and effectiveness of the optic nerve decompression surgery.
   
The procedure was intended to relieve pressure on the optic nerve and
improve vision. More than 1,000 decompression surgeries are performed
each year by U.S. doctors.
   
Based on the study's findings, the safety monitoring committee
suggested in October 1994 that the surgical procedure be discontinued
because it was useless and potentially harmful.
   
"The outcome of this study was surprising, and it was an important
outcome," Johnson said in an interview from a North American
Neuro-Ophthalmology Society meeting in Tucson, Ariz. "No one expected
the surgery to make things harmful."
   
This condition is more common among white individuals and those with a
recurrent history of fever blisters. Other risk factors include
hypertension, diabetes and a certain condition of the optic nerve that
can be noticed only during an examiniation by an ophthalmologist.
   
Johnson said researchers in the trial found that more than 40 percent
of those who received no treatment had improved vision, while the
surgical group's vision worsened.
   
These results suggest that decompression surgery could be ineffective,
he said.

[Eye Nerve Surgery Could Cause Harm, Mary Bender, Digital Missourian,
February 21, 1995]

An operation performed on thousands of patients with optic nerve
compression is ineffective and may be harmful, the National Eye
Institute reported Tuesday.
   
A study of 244 eye patients showed the surgery to be "neither safe nor
effective" against the condition--non-arteritic ischemic optic
neuropathy--which can cause a sudden and drastic type of vision loss,
the researchers said.
   
"We're coming out very strongly that from this point on there should be
no more surgery done of this kind," Dr. Shalom Kelman, a University of
Maryland neuro-ophthalmologist and chairman of the study, said Tuesday.
   
The details of the study are to appear in today's issue of the Journal
of the American Medical Association.
   
The eye institute, part of the National Institutes of Health, had warned
physicians last October that early clinical tests showed the procedure
was not as effective as originally believed.
   
The surgery is the only treatment for the eye disorder, which comes from
a swelling behind the area where the retina and optic nerve meet. The
affliction is the most common cause of sudden visual loss in the
elderly, affecting one in every 250,000 people. Each year, 1,500 to
6,000 people are diagnosed with the problem, with varying degrees of
severity. In 45 percent of the cases, visual sharpness can drop to the
level defined as legally blind.
   
A small study published in 1989, the year the surgery was developed,
suggested that it relieved the eye condition, and other small studies
supported this finding. But the large clinical trial sponsored by the
National Eye Institute--which compared the results of surgery to the
results when patients had no treatment--concluded that surgery is
actually likely to make things worse.
   
After six months of follow-up with patients, the study showed that 43
percent of those without surgery had improvement in their vision, while
only 33 percent of those who had undergone surgery improved.

[Warning on Eye Surgery, Expert Calls for End to Ineffective Treatment,
Newsday, February 22, 1995]

An eye operation routinely done to correct the most common cause of
sudden loss of vision in people 60 and older has been found to be so
ineffective, and possibly harmful, that federal health officials are
warning eye surgeons to stop doing the procedure.
   
A national study of the operation, which quickly became the standard
treatment after it was first reported in 1989, was halted last October,
years ahead of schedule.
   
The eye condition, known as non-arteritic ischemic optic neuropathy,
comes on so suddenly that those affected by it often awake with their
vision gone in one eye.
   
In 40 percent of those affected, loss of vision can eventually develop
in both eyes. The condition results from a painless swelling of the
optic nerve that connects the eye and the brain.
   
The cause is unknown, but ophthalmologists have long suspected that it
is caused by pressure on the optic nerve. The purpose of the operation
is to relieve such pressure, but the findings of the study challenge
that theory.
   
The study, sponsored by the National Eye Institute, found that those who
had no treatment at all recovered their vision after a period of six
months at a rate considerably higher than those who had the surgery.
   
The study also raised the possibility that the procedure might be
harmful.
   
Those in the surgical group had a greater loss of visual acuity than
those who had no treatment.
   
[Warning on Common Eye Surgery, San Francisco Chronicle, February 22,
1995]

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