Exposing the LASIK Scam

New ocular syndrome surfaces with IntraLase

by Matt Young EyeWorld Staff Writer

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.

Complete article is available at http://www.eyeworld.org/Aug04/0804_p12.html

OCULAR SURGERY NEWS 10/1/2004

Transient light sensitivity a minor complication of IntraLase use

The syndrome affects less than 1% of IntraLase patients and resolves quickly with aggressive steroid use.

"Now that it's been identified, it's great. When patients show signs, I can put a name to it."
? Daniel S. Durrie, MD

A syndrome investigators are calling transient light sensitivity has been identified as a postoperative complication of IntraLase flap creation. The syndrome, which does not affect visual acuity, is seen in less than 1% of patients and typically resolves with a short, aggressive course of steroids.

Some users of the IntraLase femtosecond laser keratome first noticed the complication when they began working with the system more than 2 years ago. Since then, the phenomenon has gone under multiple names.

?Patients would walk into the office with two pairs of sunglasses on and a baseball cap,? said Brian R. Will, MD, director of Will Vision & Laser Centers in Vancouver, Wash. ?No one knew what to make of the symptoms ? light sensitivity, preserved visual acuity and no slit-lamp findings.?

Dr. Will coined the term track-related iridocyclitis and scleritis (TRISC) syndrome to describe the condition he thought was due to gas bubbles and debris migrating toward the limbus during LASIK with IntraLase.

Karl G. Stonecipher, MD, another early user of IntraLase, called the syndrome good acuity plus photophobia (GAPP). ?It?s similar to the late-onset inflammation we once saw with PRK,? Dr. Stonecipher, of Greensboro, N.C., told Ocular Surgery News. He believed that the inflammation was due to activated keratocytes in the interface.

As time passed, speculation grew among users. Surgeons became concerned about the cause and identity of the rare aftereffect of IntraLase flap creation.

?It was scary when we didn?t know what it was ? frightening to the surgeon and the patient,? said Daniel S. Durrie, MD, director of Durrie Vision in Overland Park, Kan.

Transient light sensitivity

In July, IntraLase surveyed users of its system and discovered that the apparent photophobia phenomenon was unique to LASIK cases using IntraLase for creation of the flap.

?Transient light sensitivity, or TLS, is the term coined by IntraLase to describe the complication,? Dr. Durrie said.

?Once TLS and an effective treatment for the syndrome were identified, it was a relief to everyone,? Dr. Will said. ?It was hard to treat something when you didn?t know what in the world it was.?

?Now that it?s been identified, it?s great,? Dr. Durrie said. ?When patients show signs, I can put a name to it, say, ?Oh, you have TLS. This is a known condition. It responds to steroids, and then it goes away for good.??

Symptoms

TLS symptoms manifest 2 to 6 weeks after surgery.

?Patients? eyes appear fine. There is no visual acuity loss, diffuse lamellar keratitis, redness, dry eye or inflammation inside or outside the eye ? just light sensitivity,? said Perry Binder, MD, of the GordonBinder Vision Institute in San Diego.

Photophobia can be mild to severe, depending on the duration of symptoms at the time patients present.

?When patients wait 3 to 4 weeks, photophobia is usually moderate and easily treated. But when they wait 6 to 8 weeks after first noticing the symptoms or the diagnosis is delayed, it?s usually much worse,? Dr. Will said. Light sensitivity typically occurs bilaterally and is more common in patients with blue irides, he noted.

Dr. Stonecipher noted a higher incidence of TLS among female patients. ?There is a female preponderance of 75%,? Dr. Stonecipher said.

Along with normal visual acuity, patients? anterior segments appear normal with no iritis, cellular flare, corneal staining or anomaly, episcleritis, or redness in the conjunctiva/sclera. Patients with severe photophobia may complain of pain on upward gaze, Dr. Will said.

Complete article is available at www.osnsupersite.com/default.asp?ID=8988

http://www.accessdata.fda.gov/scripts/c ... _ID=533139

INTRALASE CORP. INTRALASE FS LASER LASER KERATOME

Model Number 20002

Issue
Visual disturbances; Surgical procedure

Problem Description

Subsequent to uneventful bilateral lasik surgery with the intralase fs laser, the pt complained of sensitivity to fluorescent lighting. Although there were no findings on the slit lamp and no loss of visual acuity, at approximately two weeks postoperatively secondary surgical intervention was performed in order to lift and rinse the flap. The patient has been referred to a neurophthalmologist. The pt is currently being treated with topical steriods and restasis.

Manufacturer Response

A device evaluation was not warranted because the laser was functioning as intended. The preventative maintenance records were reviewed for this laser and showed that a pm visit was performed in 04/2004. At the pm visit the laser performed within specifications.

http://www.ophmanagement.com/article.aspx?article=86298

One complication that has been reported in about 1% of patients whose flaps have been cut by the FS laser is a syndrome called Delayed Acute Photophobia (DAP), or as IntraLase prefers to call it, Transient Light Sensitivity (TLS). This condition manifests itself as an extreme sensitivity to light, but with no loss of visual acuity. The onset of TLS usually occurs 2 to 6 weeks post-LASIK and can last from 2 to 6 months if not treated promptly with a short, aggressive course of steroids (Pred Forte) and sometimes cyclosporines (Restasis). Some surgeons are now recommending steroid treatment in the days immediately following surgery as a way to prevent the occurrence of TLS.

Though the exact cause of TLS is still uncertain, some surgeons believe that the inflammation is caused by necrotic cellular debris, a byproduct of the gas bubbles that are formed to create the flap. Others speculate that the cause may be inflammatory cykotines migrating from the flap interface and sidewall to the perilimbal sclera and iris base.

"It was scary when we didn't know what it was -- frightening to the surgeon and the patient," says Dr. Durrie. "Now, that it's been identified, I can put a name to it and say, 'Oh, you have TLS.' "

This TLS sounds like what I have and I'm almost 6 months postop. Besides the horrible starbursting at night, I also notice that when watching tv, I get reflections. I can turn my head from side to side and see tv screen reflections in my own eyeball.

I'm willing to bet that you have some TLS and/or flap edema AND fairly high surgically induced higher order aberrations.

There are lots of us running around with glasses, terrible starbursts at night and a host of other weird visual disturbances after LASIK. You won't feel LONELY here Jons!

Watch TV with all the lights on in the room. Keeps the TV from shooting off weird glowing smears - or at least lights reduce the problem.

J Cataract Refract Surg. 2006 Jan;32(1):91-4.


Transient light sensitivity after femtosecond laser flap creation: clinical findings and management.

Stonecipher KG, Dishler JG, Ignacio TS, Binder PS.

Southeastern Laser and Refractive Center, Greensboro, North Carolina, USA.

PURPOSE: To describe the constellation of subjective and objective findings associated with unusual occurrences of photosensitivity after laser in situ keratomileusis (LASIK) with femtosecond flap creation and identify optimal management strategies.

METHODS: Demographic data, laser settings, subjective complaints, clinical findings, treatment, and response to treatment were recorded for suspected cases of transient postoperative photosensitivity from 3 surgeons operating at 3 different sites. All cases were estimated for the period covering the suspected cases at each site to assess incidence. Additional cases were solicited from IntraLase users via a survey.

RESULTS: For the 3 sites, 63 eyes from 33 patients were reported of a total estimated case log of 5667 (incidence, 1.1%). Average age was 41 years, and 51.7% of patients were women. Onset of symptoms ranged from 2 to 6 weeks after uneventful LASIK. All patients were treated with prednisolone acetate drops, whereas 1 surgeon also used Restasis (cyclosporine ophthalmic solution 0.05%). Patients noted improvement of symptoms within 1 week of treatment. When the raster and side-cut energy settings were lowered (by an average of 24% and 33%, respectively), significant reductions in incidence were noted. Similar findings were reported by 3 additional surgeons reporting 17 cases in the survey of IntraLase users.

CONCLUSIONS: This report describes a new complication of LASIK performed with a femtosecond laser keratome that may be related to the pulse energy used for flap creation. Although there is no loss of uncorrected visual acuity, symptoms can be prolonged, especially without prompt steroid therapy. Technical advances that reduced pulse energies appear to decrease the incidence.

J Cataract Refract Surg. 2006 Dec;32(12):2075-2079.

Transient light-sensitivity syndrome after laser in situ keratomileusis with the femtosecond laser Incidence and prevention.

Munoz G, Albarran-Diego C, Sakla HF, Javaloy J, Alio JL.

From the Refractive Surgery Department Centro de Especialidades Marques de Sotelo and Hospital NISA Virgen del Consuelo (Munoz, Albarran-Diego), Valencia, and the Refractive Surgery Department (Munoz, Sakla, Javaloy, Alio), VISSUM Instituto Oftalmologico de Alicante, Alicante, Spain.

PURPOSE: To describe the incidence of transient light-sensitivity syndrome (TLSS) after laser in situ keratomileusis (LASIK) with the femtosecond laser and to identify preventive strategies.

SETTING: Hospital NISA Virgen del Consuelo, Valencia, Spain.

METHODS: The first 765 eyes operated on with the 15 KHz femtosecond laser were prospectively analyzed for subjective complaints and clinical findings compatible with TLSS. Intraoperative settings, postoperative treatment, and development of complications were analyzed.

RESULTS: Overall, TLSS developed in 10 eyes (incidence 1.3%). However, the incidence decreased from 2.8% to 0.4% when aggressive topical steroids were used during the first 3 postoperative days. Postoperative interface inflammation and postoperative use of a low-dose topical steroid regimen were associated with a higher incidence of TLSS.

CONCLUSIONS: Transient light-sensitivity syndrome is a relatively uncommon complication related to the use of the femtosecond laser. Postoperative interface inflammation may increase the probability of developing TLSS, whereas an aggressive postoperative steroid regimen seemed to provide protection against it.

Confocal Microscopy Comparison of IntraLase Femtosecond Laser and Moria M2 Microkeratome in LASIK

Journal of Refractive Surgery Vol. 23 No. 2 February 2007

Jaime Javaloy, MD, PhD; Mar?a T. Vidal, MD, PhD; Ayman M. Abdelrahman, MD, MSc; Alberto Artola, MD, PhD; Jorge L. Ali?, MD, PhD