Sunrise Hyperion LTK system receives FDA approval

The Hyperion LTK system is the first refractive laser procedure designed specifically for hyperopia.

Issue: August 1, 2000

FREMONT, Calif. — The U.S. Food and Drug Administration (FDA) has approved Sunrise Technologies’ Hyperion Laser Thermal Keratoplasty (LTK) system. Approval of the premarket approval application for the Hyperion LTK system is for the temporary reduction of hyperopia in patients with +0.75 D to +2.50 D of manifest refraction spherical equivalent with less than or equal to ± 5 D of astigmatism, who are 40 years of age or older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0.5 D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their refractive correction.

“A 3-second procedure for re-treatment is going to be a lot less involved than doing another flap and going through hyperopic laser in situ keratomileusis,” Sandra C. Belmont, MD, FACS, clinical investigator for Sunrise Technologies, told Ocular Surgery News. “Hyperopia is something that continues as the patient ages. That is going to happen with any hyperopia procedure.”

How it works

The procedure utilizes laser energy to gently reshape the cornea without touching the eye. No scalpel incisions or laser ablations are used to cut or remove a patient’s corneal tissue.

A holmium:YAG laser, which uses a process for shrinking collagen, applies two concentric rings of eight simultaneous spots of laser energy to the periphery of the cornea to gently heat the corneal collagen and steepen its shape. This is performed to improve the cornea’s refractive power. No tissue is cut and no instruments touch the eye, thus, the possibility of intraoperative complications, postoperative infections, or risk of healing abnormality that may have an effect on vision is reduced.

“The patient is usually 0.5 D overcorrected,” Dr. Belmont said. “Patients tend to have a fluctuation in visual acuity for the first 2 to 3 months postoperatively where they lose that extra 0.5 D.”

This system is designed for in-office use and does not require a sterile environment, special wiring, expensive disposables or special gases.

Clinical evidence

During clinical trials utilizing the Sunrise Hyperion LTK procedure, patients usually had improved vision immediately after the procedure, with most being able to return to work and resume daily activities the day after treatment. “Some patients are immediately exhilarated by their changes in vision,” Dr. Belmont said. “In other patients, it takes 24 hours. It really depends upon how the patients’ cornea responds to drying.” Patients go through a 3-minute period where the cornea is let to dry naturally prior to lasering. Patients with eye dryness required lubricating drops through the first 24 hours after surgery, Dr. Belmont said.

Topical anesthetic eye drops were used prior to the procedure and patient complaints of postoperative pain or discomfort were usually minimal, lasting about 24 hours or less. When necessary, over-the-counter analgesics were recommended, such as ibuprofen or acetominophen, and were normally discontinued within 1 to 2 days.

The approval of the application was based on clinical trial results whereby at 12 months postoperatively, 407 eyes were corrected to 20/40 or better and 179 patients were corrected to 20/20 or better visual acuity.

Long-term risks of LTK for hyperopia have not been determined. “I don’t foresee any,” Dr. Belmont said. “I have done endothelial cell counts showing that there isn’t any change in the endothelium, which would be a concern.”

The safety and effectiveness of re-treatment procedures with the Hyperion LTK system have not been established. “During the past 5 years that we have been doing these procedures, there hasn’t been an increase in cataracts and there hasn’t been any sight-threatening complications,” Dr. Belmont said. “It is actually one of the safest refractive procedures and was the first allowed by the FDA during the trials to do bilateral surgery.”

In July 1999, the FDA’s Ophthalmic Devices Panel unanimously voted not to recommend the Hyperion system for approval, saying the effect of the treatment was not stable. Earlier this year, Sunrise changed its labeling request to state the effect diminished over time and then quantified exactly what that rate was in the labeling (see “FDA panel recommends Hyperion for approval,” Ocular Surgery News, February 15, 2000 issue, page 19).

For Your Information:

Sandra C. Belmont, MD, FACS, can be reached at 755 Park Ave., New York, NY 10021; (212) 746-0224; fax: (212) 746-3002. Dr. Belmont has no direct financial interest in any of the products mentioned in this article, nor is she a paid consultant for any companies mentioned.

Sunrise Technologies can be reached at 3400 W. Warren Ave., Fremont, CA 94538; (510) 771-2389; fax: (510) 771-2292.