News on LASIK and
Other Refractive Eye Surgery

As More Drug-Resistant Bacteria Develop, Researchers Evaluate Risk to Refractive Surgery Patients

SEOUL, Korea, June 2009 — Infections are rare in LASIK and other refractive surgery, but a study has found that infection rates are slowly rising. The trend seems to be part of the larger trend of infections from coagulase-negative staphylococci (CNS) and methicillin-resistant staphylococcus aureus (MRSA) in communities worldwide.

Researcher Kyoung Yul Seo, MD, and colleagues evaluated infection risk in 105 patients by taking swab samples from the surface of their eyes before they had refractive surgery. CNS appeared in 84.9 percent of the cultures grown from the samples; 31.4 percent was methicillin-resistant. In other studies during the past 10 years, resistant CNS appeared in fewer than than 2 percent of samples.

The researchers used five fluroquinolone antibiotics to treat the bacteria, but it was the one most recently approved by the FDA that was most effective. Dr. Seo's opinion was that using newer drugs as initial treatment may limit the ability of these bacteria to produce resistant mutations.

"Since resistant CNS is now widespread, it makes sense to develop ophthalmic agents using the newest fluroquinolones and to consider their use after refractive surgery to attempt to reduce infections," said Dr. Seo in a news release. The research was based at Yonsei University College of Medicine in Seoul.

New Company Hopes To Produce Laser Procedures for Presbyopia

MUNICH, Germany, May 2009 — A new joint venture between Bausch & Lomb and 20/10 Perfect Vision AG will focus on laser-based treatments for presbyopia, the eye condition that makes it difficult for just about everyone to read or do close work after age 40.

The new company, Technolas Perfect Vision, will work on procedures such as IntraCOR, which stands for intrastromal correction of presbyopia. IntraCOR uses a femtosecond laser to remove tissue in the main part of the cornea (the stroma), without cutting the cornea or its outer layer (epithelium). According to researchers, this method maintains the structural integrity of the cornea, has a low infection rate and promotes wound healing.

IntraCOR researcher Mike P. Holzer, MD, outlined the procedure in Cataract & Refractive Surgery Today Europe in January. The report says that IntraCOR takes about 20 seconds, during which gas bubbles form in the cornea. Vision is blurry for two or three hours, but when the gas bubbles dissolve, the cornea is clear again, distance vision returns and near vision has improved. Near vision improves even more for most people by the next day.

IntraCOR isn't FDA-approved yet, but it has the European CE Mark for treatment of presbyopic hyperopes. Studies are underway for a wider range of uses.

Study Says That for High Nearsightedness, LASIK Has Limited Predictability

HELSINKI, Finland, March 2009 — Forty-seven LASIK patients who started with 9 diopters or more of myopia were examined at one, three, six and 12 months, and between two and five years after surgery. (The surgeries took place from 1999 to 2003.)

Researchers found:

Forty percent of eyes attained vision within one diopter of the intended goal.
Seventy percent were within two diopters.
Ninety-one percent were within three diopters.

Over time, most of the eyes regressed mildly but significantly toward myopia during the two-to-five-year period.

The researchers concluded that LASIK is safe and moderately stable, but for people with high myopia (-9.00 to -17.00 diopters), its predictability is limited.

Still, all the patients but one said they were very satisfied and would have chosen LASIK again.

The study was reported in the February issue of Journal of Refractive Surgery.

PresbyLASIK Frees Many People From Bifocals

McHENRY, Ill., March 2009 — An investigational laser vision correction procedure known as PresbyLASIK freed most middle-aged people from the need to wear bifocals or reading glasses during one clinical trial.

About 99 percent of more than 100 PresbyLASIK patients (average age 53) had little or no need for eyeglasses after a six year follow-up, said Robert L. Epstein, MD, director of Mercy Center for Corrective Eye Surgery.

The investigational laser procedure uses an excimer laser to create multiple zones on the eye's clear front surface or cornea, enabling clear sight at near, intermediate and far distances.

PresbyLASIK is being investigated as a way to solve vision problems of people who develop presbyopia beginning at around age 40, when near vision typically begins to blur. Bifocals, progressive lenses or reading glasses usually are needed to correct presbyopia.

Corneal Inlay Shows Promise for Presbyopia Correction

ISTANBUL, November 2008 — Most of 39 ACI-7000 corneal inlays inserted into the front of the eye to correct presbyopia helped eyes achieve 20/20 or better near vision, according to researchers at Beyoglu Eye Research and Education Hospital in Istanbul.

Study results reported in the November issue of the Journal of Cataract and Refractive Surgery showed that three inlays needed to be removed from eyes, but with no adverse consequences.

One-year study results demonstrated that:

85.3 percent of eyes implanted with the inlays achieved 20/20 or better uncorrected near vision.
All eyes achieved 20/32 or better near vision.

Corneal implants in the Istanbul study did not impede distance vision, which can be an issue with other forms of presbyopia surgery. Corneal implant procedures also are reversible.

As demonstrated by the Istanbul study, early investigations of corneal onlays and inlays for surgical correction of presbyopia have been promising. Currently the ACI-7000 (AcuFocus and Bausch & Lomb) is undergoing FDA clinical trials to test safety and effectiveness.

FDA Clears New-Generation Laser for Creating LASIK Flaps

SANTA ANA, Calif., June 2008 — Advanced Medical Optics (now Abbott Medical Optics, AMO) has received FDA clearance for a new-generation femtosecond laser for creating a thin flap on the eye's surface during LASIK.

In a LASIK procedure, the laser-created flap is lifted and a different kind of laser, known as an excimer laser, then reshapes the eye's surface for vision correction.

The newly approved laser, known as the iFS Advanced Femtosecond Laser, has advanced capabilities such as the ability to complete a flap in less than 10 seconds, according to AMO.

The new laser also can create flaps in elliptical form, which increases surgeon options to address individual vision correction needs.

Does Quality of Life Improve After LASIK?

WASHINGTON, April 2008 — Visual function as measured by what's seen on an eye chart is one way of determining success following a LASIK surgery procedure.

But the FDA wants to clarify whether LASIK actually improves quality of life.

To do this, the agency will undertake a major study in 2009 in cooperation with the National Eye Institute, American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.

The study will assess quality of life following LASIK based on factors such as general satisfaction beyond how eyesight is traditionally assessed.

Between 1998 and 2006, the FDA reported receiving 140 comments from people unhappy with the outcomes of LASIK procedures.

Study Finds High Satisfaction Rate With LASIK

FAIRFAX, Va., March 2008 — About 95 percent of the more than 16.3 million people worldwide who have undergone LASIK eye surgery are satisfied with their results, according to the American Society of Cataract and Refractive Surgery (ASCRS).

"We find that there is solid evidence in the world's scientific literature to affirm that there is an exceptionally high level of satisfaction in patients who have had LASIK surgery," said ASCRS president Richard L. Lindstrom, MD.

ASCRS based its conclusions on a review of nearly 3,000 peer-reviewed articles appearing in scientific and medical journals worldwide.

Lindstrom acknowledged that risks are still involved and some outcomes are unfavorable, which is why eye surgeons continually seek to improve technology and techniques.

Researchers who reviewed scientific literature said successful outcomes also involve selecting appropriate candidates for LASIK based on factors such as eye health.

Dry Eye After LASIK Linked to Low Tear Production

BOSTON, March 2008 — People who don't produce enough tears could be poor candidates for LASIK eye surgery, according to Schepens Eye Research Institute scientists.

Researchers identified specific low levels of tear production that could be linked to dry eye problems following LASIK. As part of the Schirmer eye test for dry eye, scientists found tear production was inadequate for LASIK at levels of less than 20 mm of moisture produced on a paper test strip during a five-minute period.

Scientists said this lower tear production level could be used as criteria for identifying people who need treatment for dry eye in advance of LASIK. In some cases of low tear production, individuals may be eliminated altogether as candidates.

Study results were published in the January issue of Investigative Ophthalmology and Vision Science.