On December 15, 2004, VISX Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) to treat farsightedness (hyperopia) and farsighted astigmatism with the VISX CustomVue (TM) Hyperopic LASIK procedure.

The FDA approval is specifically for the company's wavefront-guided LASIK procedure.  The enhanced CustomVue (TM) procedure involves detailed WaveScan (R) measurements of the patient's vision problems.  These wavefront-guided measurements help provide a more precise and customized vision correction treatment than a standard LASIK procedure. 

The FDA approval covers treatments of up to 3.00 diopters (D) of hyperopia without astigmatism and up to 2.00 D of farsighted astigmatism. (The spherical equivalent of a hyperopic prescription with astigmatism must not exceed +3.00 D.)

With this approval, VISX's CustomVue (TM) procedure becomes the first wavefront-guided laser treatment for hyperopia in the United States.

Colman Kraff, M.D., principal investigator with the VISX (R) multi-center clinical study, states, "VISX's new CustomVue Hyperopia procedure is a significant step forward in the treatment of farsightedness. The overall quality of vision with this new procedure is so superior that I plan to treat all of my qualified patients with CustomVue Hyperopia."

A six-month evaluation of clinical study participants showed that more than four times as many people were very satisfied with their night vision after the VISX CustomVue (TM) procedure for hyperopia when asked to compare it to their night vision with eyeglasses or contacts prior to the surgery. The VISX clinical study results also exceeded all of the FDA required parameters for safety and effectiveness.

More About VISX CustomVue (TM) Wavefront-Guided LASIK for the Correction of Nearsightedness, Farsightedness and Astigmatism

Indications and Intended Uses

The VISX STAR S4 Excimer Laser System and WaveScan (R) WaveFront System is now approved to perform wavefront-guided LASIK treatments for the reduction or elimination of:

• Nearsightedness (myopia) up to -6.00 diopters (D), with up to 3.00 D of astigmatism. (The spherical equivalent of a myopic prescription with astigmatism cannot exceed -6.00 D.)

• Farsightedness (hyperopia) up to +3.00 diopters (D), with up to 2.00 D of astigmatism.  (The spherical equivalent of a hyperopic prescription with astigmatism cannot exceed +3.00 D.)

Results of the Clinical Trial for Nearsightedness and Astigmatism

Approval of the CustomVue (TM) LASIK procedure for nearsightedness (myopia) and astigmatism  is based on a clinical trial of 351 eyes. Of all eyes treated, 318 were evaluated at 3 months after surgery, 277 eyes were evaluated at 6 months, 102 eyes were evaluated at 9 months, and 86 eyes were evaluated at 12 months after surgery.

The study found that at 6 months after CustomVue (TM) LASIK:

• 100 percent of the 71 eyes that had nearsightedness without astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 95.8% could see 20/20 or better.

• 99.5 percent of the 206 eyes that had both nearsightedness and astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 93.2% could see 20/20 or better.

In a very few cases, CustomVue (TM) LASIK may cause a loss of best spectacle-corrected visual acuity (BSCVA).  In other words, a person who can be corrected to 20/20 with eyeglasses prior to surgery may have permanently less clear vision after surgery that cannot be corrected to 20/20 with eyeglasses. 

The study showed that at 3 months after CustomVue (TM) LASIK, 1 of the 239 eyes that had both nearsightedness and astigmatism before surgery (0.4%) had a BSCVA after surgery that was up to two lines worse on a visual acuity wall chart.  No eyes in the study that had only nearsightedness before surgery (without astigmatism) had a similar loss of visual acuity.  During the course of study, no eye lost more than two lines of BSCVA and no eye had a BSCVA worse than 20/40.

The clinical trial for nearsightedness and astigmatism showed that the following adverse events or complications occurred in at least 1% of the 351 eyes at any interval up to 6 months post-treatment:

• Inflammation of the cornea under the flap (1.4%)

• Double or ghost images (1.4%)

• Scratch(es) on the surface of the eye (1.4%)

At 6 months after CustomVue (TM) LASIK, a higher percentage of participants in the study felt the following subjective symptoms occurred "often or always" compared to before surgery:

• Dryness (9% vs. 6%)

• Fluctuation of vision (3% vs. 2%)

• Glare (4% vs. 2%)

• Halos (7% vs. 5%)

Results of the Clinical Trial for Farsightedness and Astigmatism

Approval of the CustomVue (TM) LASIK procedure for farsightedness (hyperopia) and astigmatism  is based on a clinical trial of 144 eyes. Of all eyes treated, 134 were evaluated at 3 months after surgery, 131 eyes were evaluated at 6 months, 118 eyes were evaluated at 9 months, and 27 eyes were evaluated at 12 months after surgery.

The study found that at 6 months after CustomVue (TM) LASIK:

• 97.3 percent of the 74 eyes that had farsightedness without astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 66.2% could see 20/20 or better.

• 93.0 percent of the 57 eyes that had both farsightedness and astigmatism before surgery could see 20/40 or better (unaided) after LASIK, and 56.1% could see 20/20 or better.

At 6 months after CustomVue (TM) LASIK, no eyes showed a loss of two or more lines of best spectacle-corrected visual acuity (BSCVA), and none of the 74 eyes that had farsightedness without astigmatism or 63 eyes that had farsightedness with astigmatism prior to surgery had a BSCVA worse than 20/25.

The clinical trial for farsightedness and astigmatism showed that the following adverse events or complications occurred in at least 1% of the 144 eyes at any interval up to 6 months post-treatment:

• Double or ghost images (11.3%)

• Cells growing under the flap (2.1%)

• Scratch(es) on the surface of the eye (2.1%)

• Feeling of something in the eye (1.4%)

At 6 months after CustomVue (TM) LASIK, a higher percentage of participants in the study felt the following subjective symptoms occurred "often or always" compared to before surgery:

• Dryness (17% vs. 6%)

• Fluctuation of vision (14% vs. 6%)

• Blurry vision (10% vs. 7%)

• Halos (10% vs. 5%)

• Double or ghost images (7% vs. 3%)

Contraindications and Warnings

Wavefront-guided LASIK is contraindicated for the following individuals:

• People with collagen vascular or autoimmune disease (e.g. rheumatoid arthritis)

• People with immunodeficiency disease

• People with signs of keratoconus or abnormal corneal topography

• People under the age of 21

• People with unstable eyeglasses prescriptions

• People taking Accutane (R) medication for acne

• People taking Cordarone (R) medication for cardiac arrhythmia

• Women who are pregnant or nursing

Wavefront-guided LASIK is also not recommended for patients who have diabetes, a history of Herpes simplex or Herpes zoster keratitis, significant dry eye that is unresponsive to treatment, or severe allergies.

Lower uncorrected visual acuity after CustomVue (TM) LASIK may be anticipated in the treatment of higher degrees of nearsightedness (over -5.00 D), with or without astigmatism.

It's possible that after wavefront-guided LASIK treatment, patients will find it more difficult than usual to see in conditions such as very dim light, rain, snow, fog, or glare from bright lights at night.  Visual performance could possibly be worsened if the patient has large or decentered pupils.

Statements regarding the potential benefits of wavefront-guided LASIK (CustomVue (TM)) are based upon the results of clinical trials. Although many clinical trial patients saw 20/20 or better after the CustomVue (TM) procedure and/or had or reported having better vision after the procedure compared to their vision with eyeglasses or contact lenses before the procedure, individual results may vary.

As with any surgical procedure, there are risks associated with the CustomVue (TM) treatment.  Wavefront-guided LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), conventional LASIK, and other refractive surgeries.

(This article was adapted from a press release that appears on VISX, Inc.'s website, www.visx.com.)