Lasik Eyes Surgery - Patients Experiencing Extreme Light Sensitivity after IntraLase LASIK

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Patients Experiencing Extreme Light Sensitivity after IntraLase LASIK

Sandy - LASIKdisaster.com - LASIKmemorial.com

2005-01-27, 8:52 am

A new ocular syndrome has caused chatter among femtosecond laser users
because of an unusual trademark: 20/20 patients with extreme light
sensitivity after LASIK.
In its short history, the syndrome has been called many names as
ophthalmologists and IntraLase Corp. (Irvine, Calif.) officials on the
forefront of its study have sought to coin their own terms for it.

Facts about TLS

? After a procedure with the IntraLase, patients have good acuity;
? No physical problem can be seen in the eyes;
? Patients are extremely sensitive to light;
? The inflammation begins at six to eight weeks post-operatively and
resolves at four to five months post-operatively; and
? The photosensitivity duration is reduced with topical application of
corticosteroids and Restasis (Allergan, Irvine, Calif.).

Source: Karl Stonecipher, M.D.

Among the terms are Good Acuity Plus Photosensitivity (GAPP), Track
Related Iridocyclitis and Scleritis (TRISC), and Transient Light
Sensitivity (TLS). TLS has been espoused by IntraLase, whose
femtosecond laser users acknowledge the phenomenon does exist, although
no peer-reviewed journal article yet exists on a syndrome with any of
these names. This article primarily uses the name TLS for clarity,
except in quotations where an alternative name was spoken.

IntraLase users said they have never seen the syndrome after making a
LASIK flap with a microkeratome blade, but only have witnessed the
problem after doing so with the IntraLase FS Laser. The
ophthalmologists - one of whom is co-medical director for IntraLase -
could only speculate as to what causes the problem, but said it is a
nuisance, not a danger.

Some disagreed, however, about the incidence of the syndrome, and
differed over what drugs should be used to treat it.

Good vision but photosensitive patients: The syndrome's signature

A little more than a year-and-a-half ago, Perry Binder, M.D.,
co-medical director, IntraLase, saw his first patient with TLS,
although at the time he didn't know it.

The patient came into his office six weeks after surgery with 20/20
uncorrected vision in both eyes after having undergone LASIK with
IntraLase but complained of severe light sensitivity.

"I looked at this gentleman and I could see nothing wrong with him,"
said Dr. Binder. "The tear film looked good. There was no redness in
the eye. There was no inflammation inside the interface. Yet, he was
extremely light sensitive."

Dr. Binder said he simply treated the patient for his symptoms "and
just assumed that there was inflammation somewhere."

Using hourly steroids for a week, the patient got better and the
phenomenon never recurred, Dr. Binder said.

But then, another similarly mysterious case surfaced four months later,
then another. Dr. Binder then discovered that there were other cases
nationwide.

"It's not a big problem at all," said Dr. Binder, who described his TLS
incidence as three cases in about 1,500 procedures. "But it does exist
and it appears to be a new entity."

Theories bubble to the surface

While physicians that have investigated TLS only could speculate as to
how the syndrome occurs, one gas-related theory has bubbled to the
forefront of the conjecture.

The theory was published by Brian Will, M.D., medical director, Will
Vision & Laser Centers, Vancouver, Wash., as part of an abstract in the
American Society of Cataract & Refractive Surgery's Abstracts book from
this year's ASCRS?ASOA Symposium & Congress, San Diego. Dr. Will
discussed this topic at the meeting.

The abstract, titled, "Track Related Iridocyclitis and Scleritis
Associated with Use of the IntraLase LASIK," suggests that the syndrome
is related to the "track," or potential space, created between the
LASIK interface and the sclera by the initial photodisruption of
IntraLase. IntraLase works by creating a LASIK flap through
photodisruption at the molecular level.

According to the abstract, the track "acts as a conduit that allows
inflammatory cytokines produced by the healing interface and sidewall
to gain access to the perilimbal sclera and iris base. These
inflammatory cytokines create a scleritis and associated inflammation
of the iris base with resulting photophobia."

Dr. Will declined to comment for this article.

Activated keratocytes in the interface also can be seen in the
interface weeks to months after surgery in cases with and without the
syndrome, which could be another cause, Dr. Binder said.

"It may be the excess keratocytes in the interface in some of these
cases - not all - that is somehow associated with the light
sensitivity," Dr. Binder said. "Basically, there could be more light
scatter that patients are perceiving as light sensitivity."

The femtosecond laser energy, which is greater than that created by a
blade, probably stimulates more wound healing, and so the body sends
keratocytes into the interface, Dr. Binder said. The gas theory and the
activated keratocyte theory may not be mutually exclusive, Dr. Binder
said.

A huge or small incidence?

Karl Stonecipher, M.D., director of laser and refractive surgery,
Southeastern Eye Center, Greensboro, N.C., has experienced TLS 20 times
in 2,645 IntraLase cases. That's a 0.76% incidence.

"I just don't think it's a big issue," Dr. Stonecipher said. "I worry
more about people getting diffuse lamellar keratitis (DLK) than I do
GAPP because I have never had a patient injured from GAPP."

What's more, Dr. Stonecipher said, since IntraLase was upgraded to the
15 kHz from 10 kHz laser, which has caused flap-making time to drop
from 90 to 60 seconds, he has only had one case of TLS.

In other words, with the 15 kHz laser, the TLS incidence dropped to one
in 1,000, he said.

J. Trevor Woodhams, M.D., medical director, Woodhams Eye Clinic,
Atlanta, said he has experienced a very high incidence of TLS - in the
range of 10% to 20% - although he did not know how many cases
specifically he has had.

"I think it's a more widespread problem than has been discussed by
IntraLase users," Dr. Woodhams said. "These patients are oftentimes
unable to function; these are very unhappy people."

TLS is one of the reasons Dr. Woodhams never fully converted from
mechanical to IntraLase keratectomy.

But like the other physicians interviewed, Dr. Woodhams said the
syndrome is not dangerous and foresaw no long-term complications
resulting from it.

Company officials said Dr. Woodhams' experience with TLS has been
outside the norm for most IntraLase users. Still, it has prompted the
company to perform a clinical study with him, which is currently
underway.

Physicians disagree over best treatment options

"What happens is the patients come in, they see 20/16 or 20/20, but
they're extremely photosensitive," Dr. Stonecipher said. Often, they
will arrive in sunglasses, he said.

"You turn off all the room lights and you show them an eye chart and
they can read it," Dr. Stonecipher said. "But they can't go out in the
waiting room without their sunglasses on because it's too bright."

A chart review of all the patients by Dr. Stonecipher with TLS revealed
an average onset of the photosensitivity at 65 days and an average
resolution by 133 days. There was no predilection to eye color or sex.
As well, degree of refractive error (myopia, hyperopia, or astigmatism)
or pre-operative scotopic and photopic pupil size showed no appreciable
trends.

TLS does not respond to nonsteroidal anti-inflammatory drugs,
cycloplegics, or pupil constriction, Dr. Stonecipher said. Rather, it
primarily responds to a combination of topical steroids and Restasis
(Allergan, Irvine, Calif.), he said.

"I will usually place the patients on a combination of Pred Forte 1%
(Allergan) four to six times a day and Restasis two to four times a
day, depending on the severity of the photosensitivity," he said. "I
will discontinue the Pred Forte at one to two weeks and continue the
Restasis until resolution."

"Restasis is not instantaneous though," Dr. Stonecipher said. "For my
patients, they will notice an improvement in symptoms at two to three
weeks and resolution around three to four months."

Daniel S. Durrie, M.D., a member of the IntraLase Medical Advisory
Board, and clinical associate professor, university of Kansas Medical
Center, Kansas City, said that he has resolved TLS symptoms by using
Pred Forte four times per day if treatment is initiated early. He also
discusses the syndrome with the patient and monitors treatment
progress.

"I have not used Restasis, but it makes sense and I will try it on the
next patient I see with this problem," Dr. Durrie said.

Although Restasis does treat inflammatory conditions, Dr. Binder said
he treats TLS with intensive steroids for a week. He tells patients to
use one drop of Pred Forte every hour for one week while patients are
awake.

"Within a day their symptoms abate," Dr. Binder said. "It goes away
very quickly."

Dr. Woodhams said even with topical steroid treatment, three of his
clinic's patients had TLS for as long as six months. Steroids would
improve their condition, but then the condition would resurface, he
said.

"The experience of dealing with photophobic patients for such a long
time has been troublesome enough to keep me from using IntraLase as my
keratome of choice," Dr. Woodhams said.

"The fact that different clinical presentations in different surgical
settings as well as different responses have been described may suggest
more than one entity may be involved," said Dr. Binder.

Editors' note: Dr. Binder is co-medical director for IntraLase. Dr.
Durrie is a member of the IntraLase Medical Advisory Board. Dr.
Stonecipher has received travel support from IntraLase. Dr.Woodhams has
no financial interests related to his comments.

--------------------------------------------------------------------------------
Contact Information
Binder: 858-455-6800, fax 858-455-0244, garrett23@aol.com
Durrie: 913-491-3737, fax 913-491-9650, ddurrie@durrievision.com
Stonecipher: 800-632-0428, fax 336-482-3774, stonenc@aol.com
Woodhams: 770-394-4000, fax 770-913-0841, trevorw@mindspring.com

Glenn - USAEyes.org

2005-01-27, 8:52 am

Not much new here. This was discussed two meetings ago and we had the
issue on our website
(http://www.usaeyes.org/faq/subjects..._intralasik.htm) months
ago. Fortunately it is always transient, never permanent, and
responds well to steroids. Incidence seems to be in the 10-20% range,
but the updated laser seems to all but stop the problem.

Yet another reason to consider PRK when applicable, or just keep the
contacts.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.

serebel

2005-01-27, 8:52 am

More old news from the town crier. This has been known for a long time
now, and yes, it is temporary.

SErebel