PCVI News Room

Custom wavefront-guided LASIK for farsightedness found safe, effective

August 27, 2008
A new custom, or wavefront-guided, LASIK surgery was recently shown to be safe and effective for the correction of up to 4.00 diopters (D) of hyperopia (farsightedness) with up to 4.00 D of astigmatism, according to a recent clinical study.

Study purpose and methods

The purpose of the study was to evaluate the safety and effectiveness of a new wavefront-guided LASIK treatment of hyperopia (with or without astigmatism) using the Zyoptix Personalized Laser Vision Correction System (Bausch & Lomb), combined with Bausch & Lomb's Technolas 217z excimer laser.

A study of this type is required in order for a new laser vision correction system to be approved for use in the United States by the US Food and Drug Administration (FDA).

The 2-year study was conducted at four separate surgical centers. A total of 159 eyes of 80 patients were treated. Patients were accepted into the study if they had up to 4.00 D of farsightedness, with or without up to 4.00 D of astigmatism.

The 1-year results of the study were presented by investigator Stephen G. Slade, MD at the recent annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS).

Results

Both uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) was evaluated after the custom LASIK treatment. (UCVA refers to how well an eye can see without glasses or contact lenses, and BCVA is how well they can see with the help of prescription eyewear.) Fewer than 40% of the eyes had UCVA of 20/40 or better prior to the procedure.

At one year after the procedure, UCVA results were: The BCVA results 1 year after the procedure were: Additionally, more patients had BCVA of 20/20 or better and 20/16 or better after the procedure than prior to surgery. (This suggests that these patients could see better with lower-power eyeglasses after the procedure than they could with higher-power glasses prior to surgery.)

Dr. Slade also pointed out that the custom wavefront-guided LASIK procedure in this study did not increase higher-order aberrations of the eye compared to pre-operative levels.

Conclusions

"We feel these are excellent results with good predictability," said Dr. Slade of the study's 1-year results.

After his presentation at the ASCRS annual meeting, he also said the researchers are planning to submit the findings of the study to the FDA for approval of the procedure for use in the United States.