LTK and LASIK are neck-and-neck in hyperopia race

Hyperopia laser treatments vie for lead in race for lucrative pre-presbyopic patient pool.

Issue: July 1, 2000

NEW YORK — Although safe and effective refractive treatments for myopia and astigmatism have been available for some time, hyperopic refractive surgery is an area that has seemed to elude the surgeon. Keratophakia, hyperopic keratomileusis, hyperopic automated lamellar keratoplasty and hexagonal keratotomy have all failed. Recently, emphasis has been placed on excimer laser surgery, holmium laser surgery, clear lens extraction and phakic IOLs with the promise of markedly improved results.

Hyperopic laser in situ keratomileusis (LASIK) has become a staple in the refractive surgeon’s armamentarium in the relatively short time that it has been approved for Visx (Santa Clara, Calif.), Summit (Waltham, Mass.) and Autonomous (Orlando, Fla.) excimer lasers. The learning curve is flattening out and patient satisfaction is high.

Meanwhile, Sunrise Technologies’ (Fremont, Calif.) Hyperion System for laser thermokeratoplasty (LTK) aims to change all that. Surgeons interviewed for this article described the procedure as quick, painless, safe and easy. “I believe LTK is going to be the forerunner for the treatment of hyperopia after approval,” said New York refractive surgeon Sandra C. Belmont, MD. “It’s a three-second procedure without any down side. It’s simple; the general ophthalmologist can perform it without a high learning curve. The holmium laser is placed in the corner of the office. You don’t need a full-time technician. You don’t need all those disposables. The investment itself is less [than LASIK] and it’s much easier to learn.”

Dr. Belmont participated in the Food and Drug Administration clinical study of the Sunrise system for LTK, which comprised 612 eyes in a little less than 400 patients. The protocol allowed for treatment of up to 2.5 D of hyperopia. Dr. Belmont treated approximately 100 patients — some with follow-up as long as 24 months. She said the ideal LTK patient is over 40 years of age and has realistic expectations. “Initially, there is an overcorrection of about 0.5 D, which dissipates over the first few months. So you want to make sure that the patient understands that his or her near vision is going to come back into focus initially and that will decrease as his or her far vision comes into focus at about 3 months. At that point, the patient should be stable. They’ve shown that it is stable out past 24 months.” Dr. Belmont pointed out that hyperopic patients over 40 usually cannot see distance or near, so they are very happy with their vision after LTK.

Safe and effective

Dr. Belmont said, “There are some surgeons who are doing LASIK for the lower degrees of hyperopia, but I believe that once LTK is approved, it is going to take over that population. If their results show that they can get good results up to +4, then it may take over the entire hyperopic population.”

Donald R. Sanders, MD, PhD, a research and regulatory consultant for Sunrise, stressed the safety profile of LTK with the Hyperion System. “We essentially had no laser-related adverse events; there was no loss of best corrected acuity among the entire patient population. The only thing that was reported was that an occasional patient noted foreign body sensation, which was treated with artificial tears. So from a safety profile, I believe that this is really a safe procedure,” he said.

The perception that hyperopic LTK regresses seems to be the fly in the ointment. But LTK investigators say it is not the procedure that falls short, rather it is the nature of hyperopia to progress. “When you graph LTK’s refractive stability along with other published articles on hyperopic photorefractive keratectomy [PRK] and LASIK, they’re virtually indistinguishable,” Dr. Sanders said. “So if you say LTK changes with time, then you have to say that LASIK and PRK change with time also, because their stability curves look identical.”

One of the reasons the LTK study outcomes look a little less attractive than those of hyperopic PRK and LASIK, he said, is because the LTK protocol did not allow for the treatment of as much hyperopia as the others. “No matter what you do, patients are going to start seeing an incremental increase in their hyperopia. We know that. But by the same token, it’s important to note that with LTK, re-treatment can be done in the office in 3 seconds,” Dr. Sanders said.

“Just as LASIK and PRK sometimes require multiple procedures, I believe that the results following 16-spot LTK with a re-treatment are going to be much better than just 16-spots alone,” Dr. Sanders said. “That’s why I believe that the results the surgeons get out in the field, once this gets approved, are going to be substantially better than the study, and the study was pretty good.”

Cost considerations

Daniel S. Durrie, MD, describes LASIK for hyperopia as a “sure thing,” with LTK following as the “one-to-watch.” “It all depends on the cost — meaning the cost for the physician to provide it,” he said. If surgeons have to charge the same amount to provide LTK as they do to provide LASIK, he believes that LTK will have a tough time competing with LASIK. “I’ve been doing holmium since 1991. I really like the procedure. I think it’s great and I’m excited to do a lot of them. But if it’s too expensive, I don’t think patients will go for it. I think they’ll say, ‘My friend had LASIK. What about LASIK?’ and I’ll say, ‘Sure.’”

Patient perception is another critical factor. “With LTK, patients are going to like the fact that it can be done in the office in a few seconds and that there’s no microkeratome,” Dr. Durrie said. “That has some real merits, but I believe it’s still going to have an awful lot to do with price. Essentially, my feeling is that LTK is going to be wildly successful as long as it isn’t too expensive. It also will increase the number of patients coming in for refractive surgery, which will also probably increase the LASIK volume because a lot of these patients will have astigmatism and won’t be a candidate for LTK since it doesn’t correct astigmatism.”

Sunrise Senior Vice President of Investor Relations Ed Coghlan said the per-procedure fee for surgeons will depend on their anticipated volume. The more procedures, the less the per-procedure fee. Mr. Coghlan said that a surgeon can turn a profit with as few as five procedures per month. He said the per-procedure fee would probably range from a little more than $200 per eye for a high-volume surgeon to about $2,000 per eye for a very low-volume surgeon . “The doctor is going to pay for the system on a per-procedure basis. We’re going to roll in the entire cost of the machine — the capital costs, the software, the upgrades for the software, the maintenance and all other costs — so that the surgeon is paid based on his or her volume. The more volume he or she promises to do each month, the lower his or her per-procedure cost will be. The break even for the surgeon is extraordinarily attractive — it’s so easy to get there,” Mr. Coghlan said.

What will it cost the patient? “That’s a question for the surgeons,” Mr. Coghlan said. “The physicians we’ve been talking to see the cost to be around what they’re charging for LASIK to perhaps 80% of what they’re charging for LASIK.”

For Your Information:

Sandra C. Belmont, MD, 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.

Donald R. Sanders, MD, PhD, can be reached at 180 W. Park Ave., Ste. 150, Elmhurst, IL 60126; (630) 530-9700; fax: (630) 530-1636; e-mail: donaldrsanders@mediaone.net. Dr. Sanders is a shareholder and a consultant for Sunrise Technologies.

Daniel S. Durrie, MD, can be reached at Eye Center of Kansas City, 5520 College Blvd., Ste. 201, Overland Park, KS 66211; (913) 491-3737; fax: (913) 491-9650; e-mail: ddurrie@novamed.com. Dr. Durrie declined to disclose whether or not he has a direct financial interest in any of the products mentioned in this article or if he is a paid consultant for any companies mentioned.

Ed Coghlan can be reached at Sunrise Technologies Inc., 3400 W. Warren Ave., Fremont, CA 94538; (510) 771-2389; fax: (510) 771-2399. Mr. Coghlan is senior vice president of investor relations at Sunrise Technologies Inc.