LadarVision system receives FDA approval for hyperopia

The system’s broad applicability is assisted by its scanning spot and eye tracking capability, which a company official called “infinitely flexible.”

Issue: November 15, 2000

FORT WORTH, Texas — The Alcon Summit Autonomous LadarVision System was approved by the U.S. Food and Drug Administration (FDA) to treat hyperopia of +6 D or less, with or without astigmatism of –6 D or less and for mixed astigmatism, using the laser in situ keratomileusis (LASIK) procedure.

The approval gives LadarVision the broadest range of approvals of all FDA-approved excimer lasers according to the manufacturer. Additionally, the LadarVision system is the only FDA-approved laser system to combine laser radar eye tracking with small scanning spot technology the company said.

The LadarVision System is also the only FDA-approved laser system to achieve these indications in a single procedure, minimizing the amount of tissue removed and eliminating potential risk of misalignment possible in second procedures, the company said.

LadarVision corners the market

In a press release, Charline Gauthier, OD, PhD, vice president and general manager of Orlando operations for Alcon Summit Autonomous said, “We’ve reached another milestone by becoming the first excimer laser manufacturer to gain approval for hyperopia with or without astigmatism, and for mixed astigmatism, using LASIK.”

Dr. Gauthier went on to explain that the approval for mixed astigmatism was of particular importance since it has recently been defined as a separate indication by the FDA.

Christy Stevens, OD, director of clinical affairs for Alcon Summit Autonomous, who oversaw the clinical results, said that the company filed for the hyperopia with astigmatism approval at the end of 1999.

She said the LadarVision system has unlimited potential because the algorithm is “infinitely flexible. You can place laser pulses anywhere on the cornea to ablate.” She also said this ability makes the LadarVision system capable of performing virtually any excimer laser refractive surgery procedure available now or likely to be so in the future and is designed to minimize tissue removed for hyperopic and mixed astigmatism corrections.

All of the LadarVision systems installed prior to the FDA approval received upgrades to their systems over a 2-week period once the approval was granted, although Dr. Stevens said the machines could have performed the procedure without the upgrades. All machines sold now will automatically have the upgrades installed.

Scott Corning, product manager for Alcon Summit Autonomous, said that once the surgeons pass the on-line training program for the newly approved indications, the system and the doctors will be capable of handling any requirement of the most advanced excimer laser system on the market.

In addition to the FDA approvals, Mr. Corning explained that there were several user-friendly improvements to the system as well. The enhanced lighting, moveable bed and improved optics are expected to improve patient throughput as well as ease of use.

“For a good clinical outcome you need a good surgeon and state of the art technology. At Alcon Summit Autonomous, we’re proud to be the first company to bring the best technology and the broadest range of FDA approvals to refractive surgeons,” Mr. Corning said.

Clinical results of LadarVision

The Ophthalmic Devices Advisory Panel of the FDA recommended the LadarVision system for approval in early 2000 after seeing the clinical trial results of patients who had undergone LASIK for hyperopia and hyperopia with astigmatism.

The results showed that at the 3- and 6-month postoperative periods, approximately 40% of hyperopic astigmatic eyes had achieved 20/20 or better. Patients with mixed astigmatism had even better visual results. Stability of vision was achieved at 3 months after the procedure and was maintained through 6 months of follow-up. Additionally, it was reported that of eyes with preoperative best spectacle-corrected visual acuity of 20/20 or better, none were worse than 20/32 postoperatively.

Fourteen investigators at 6 sites within the United States conducted the clinical trials. Surgical parameters included total ablation zone of 9 mm, with a 6-mm optical zone and a 1.5-mm blend zone. In all, 360 eyes of patients with a mean age of 53 were enrolled in the clinical trial. The majority of the study population was white. Three hundred forty-four eyes were available for 3-month postoperative evaluation, and 6-month data were available for 271 eyes.

There was an 11.4% retreatment rate, mostly for undercorrections but also including 1.1% for induced cylinder and only 0.3% for overcorrection. At 3 months or later after retreatment, 40% of patients had uncorrected visual acuity of 20/20 or better, 75% had 20/25 or better and 91.7% had 20/40 or better. There were no more than two lines of best corrected visual acuity (BCVA) lost, and no patients with BCVA worse than 20/40.

In 1995, Summit Autonomous was the first to receive FDA approval for an excimer laser system for the correction of mild to moderate myopia in the U.S., and in 1999 became the first commercial excimer laser manufacturer to receive FDA approval for LASIK the company said.

For Your Information:

Scott Corning can be reached at Summit Technology, Inc., 21 Hickory Dr., Waltham, MA 02451; (781) 672-0388; fax: (781) 890-0313; scott.corning@summitautonomous.com.

Charline Gauthier, OD, PhD, and Christy Stevens, OD, can be reached at 2501 Discovery Dr., Orlando, FL 32826; (407) 384-1600; fax: (407) 384-1699; Christy.Stevens@autonomous.com.