VISX CustomVue™ Hyperopia Procedure Approved by the FDA First U.S. Custom Wavefront LASIK Approval for Farsightedness and Astigmatism
FORT MYERS/NAPLES – VISX announced on Thursday that it has received approval from the U.S. Food and Drug Administration (FDA) to treat hyperopia and hyperopic astigmatism with the VISX CustomVue Hyperopic LASIK procedure.The FDA approval allows for WaveScan® diagnosis and CustomVue™ treatment of patients with farsightedness and astigmatism. This approval is specifically for wavefront-guided LASIK for correction of hyperopia with or without astigmatism up to +3.00 diopters sphere with cylinder up to +2.00 diopters.
“We’re excited to now be able to treat hyperopic patients with the CustomVue procedure,” said local LASIK specialist Jonathan M. Frantz, MD, FACS. “With the most recent FDA approval, CustomVue LASIK can now be performed on patients with up to +3.0 to -6.0 diopters sphere and up to -3.0 diopters cylinder.
When the FDA first approved the CustomVue procedure in mid-2003, it allowed Dr. Frantz and other VISX-certified ophthalmologists to take the digital information acquired from the WaveScan Map and transfer it to the laser, providing a new level of precision and accuracy. “At that time, CustomVue could only be performed on myopic patients with or without astigmatism. If a patient falls outside the parameters approved by the FDA, we can still perform a conventional LASIK procedure on them,” added Dr. Frantz.
The CustomVue procedure is the first U.S. approved wavefront-guided laser treatment for 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 hyperopia procedure, compared to their night vision before with glasses or contacts. The VISX clinical study results also exceeded all of the FDA required parameters for safety and effectiveness.
Dr. Frantz was the first ophthalmologist in the area to offer the VISX WaveScan System in September 2002, which brought a level of personalization to the LASIK procedure previously unavailable in this area.
Honored as one of the top providers of laser vision correction in the United States by VISX, Inc., Dr. Frantz has been performing Laser Vision Correction since 1987 and was the original principal investigator of the FDA clinical trials that led to the initial approval of the Excimer laser. Dr. Frantz performed the first Excimer laser procedure in the State of Florida for nearsightedness, farsightedness and astigmatism.
Dr. Frantz provides laser vision correction at the main offices of Florida Eye Health on New Brittany Boulevard in Fort Myers and in his Naples office at 2100 N. Tamiami Trail at Gateway Plaza.
For more information call The Center for Laser Vision Correction in Fort Myers at 791-2020 or in Naples at 430-3939 for a complimentary screening or visit the Florida Eye Health website at