Noninvasive presbyopia correction technique shows great promise

A modified method of thermal keratoplasty offers the comfort of a quick and easy procedure with no risks involved, a clinician says.

A novel technique may correct presbyopia through a temporary, repeatable procedure.

“The approach is similar to that of dermal fillers and Botox (botulinum toxin type A, Allergan) in the cosmetic field: It is effective, noninvasive, comfortable and rapid. Although temporary, with a duration that varies according to the individual response, it can be repeated whenever needed,” K. Jonathan Rodgers, MD, told Ocular Surgery News.

Optimal keratoplasty (Opti-K, NTK Enterprises) is an improved method of laser thermal keratoplasty in which anterior stromal heating is used to induce corneal shape changes while protecting the corneal epithelium from thermal damage.

The holmium laser utilized for laser thermal keratoplasty in the past produced good results, but the power used was too high and caused epithelial damage. The consequent healing activity resulted in rapid regression.

“The laser we use now differs from the holmium laser [because] it operates in a continuous wave mode rather than a repetitively pulsed mode. In addition, a special delivery system cools down the epithelium while laser energy penetrates into the cornea, protecting the epithelium from thermal damage,” Dr. Rodgers said.

The U.S. Food and Drug Administration’s clinical trial is in progress for hyperopia correction by Opti-K. A CE mark has been obtained in Europe, and Opti-K treatments have started in England and will soon start in other European countries.

Laser

The laser operates at a wavelength of 1,930 nm with 150 ms pulse duration and variable power, up to 3 W. It delivers 16 paracentral spots of energy through a sapphire applanation window held in contact with the cornea by suction.

“The sapphire is transparent to laser light and provides cooling of the epithelium by thermal conduction so that the temperature rise is less than the threshold at which thermal damage is produced to the epithelium but is sufficient to induce corneal shape changes by heating the anterior corneal stroma,” Dr. Rodgers said.

The simple procedure only takes 2.5 seconds. Patients see well immediately and experience no discomfort.

“It’s a procedure [that] patients can do during a lunch break from work,” he said. “They go back immediately and nobody will notice anything — only they’ll see remarkably better.”

Vision results

According to Dr. Rodgers, the procedure enables patients to achieve between J3 and J1+ of near vision without any loss of distance vision. For reasons still unknown, distance vision improves and patients can see 20/20 or better.

“It’s similar to another phenomenon that I witnessed when I started doing LASEK and visited Dr. Alberto Osio in Mexico 10 years ago,” Dr. Rodgers said. “He was performing LASEK in patients who were in their 50s or 60s and got tremendous results like 20/25 to 20/20 at distance and J3 to J1+ at near. He was not creating a multifocal cornea but inducing a little bit of myopia and a little bit of astigmatism, which resulted in a very small conoid of Sturm, close to the retina, which allowed people to see near and far. Presbyopia is a strange condition. There are many factors that determine how well you see at close other than the mere ability of the lens to accommodate in the eye.”

Adjustable, repeatable procedure

Indications for Opti-K include all degrees of plano presbyopia and low hyperopia up to 2 D to 4 D. Caution should be used not to overtreat, but a slight undercorrection is not a problem because refractive adjustment can be done immediately.

Both near and distance vision are measured once the patient leaves the operating table. If 20/20 and J1+ are not achieved, the patient is repositioned for a touch-up.

“We do it on the spot rather than 6 weeks later, and patients go away thoroughly satisfied,” Dr. Rodgers said.

The duration of the correction varies by individual from 3 months to 2 years. However, 24 months after the procedure, the majority of plano presbyopes can still see J2 to J3, enabling them to read a newspaper or telephone directory without spectacles if lighting is sufficient.

Patients can return to have the procedure refreshed at any time. It can be performed an indefinite number of times.

“We are doing no harm to the eye and the procedure can be repeated as needed, provided that the ocular surface is healthy,” Dr. Rodgers said. “The advantage, besides its complete safety, is also the ability to titrate the treatment to the stage of presbyopic and hyperopic shift occurring at different points in time. Rather than change spectacles, you redo the treatment.”

Dr. Rodgers started using Opti-K 4 years ago in his practice in Nassau, Bahamas, and has treated about 500 eyes so far. Approximately 90% of his patients see J1+ after treatment and are extremely happy because they have instantaneous results with no discomfort. In addition, the procedure is provided at a reasonable price.

“If you think that spectacles also have a cost, this is a very affordable method. I charge $1,000 U.S. for the two eyes, and people can come and redo the touch-up within 1 year for no extra charge,” he said.

Of all the methods he has tried for correcting presbyopia, this one is his favorite. He said it satisfies the needs of most presbyopic patients.

Other methods are more invasive and none match the results of Opti-K, he said.

“[This] technique that is quick to perform, painless, safe, risk-free, produces no anatomical damage in the eye and works so well has all the characteristics to make doctors and patients happy. The reason why it is not yet so widespread is that the holmium laser has a bad reputation due to the previous techniques of thermal keratoplasty,” he said. – by Michela Cimberle

• K. Jonathan Rodgers, MD, can be reached at Vision Rejuvenation Center, Harbour Bay Shopping Center, Nassau, Bahamas; +1-242-380-8000; email: kjarodgers@gmail.com.
• Disclosure: Dr. Rodgers received an honorarium for clinical trials 2 years ago and for travel related to NTK Enterprises.

Alain Telandro

From what the author says, the new Opti-K (NTK Enterprises) procedure seems to have overcome the drawbacks of thermal keratoplasty, basically by a system of corneal surface cooling. It also seems to be totally harmless, and this is, of course, the crucial point, particularly in consideration of the fact that the treatment needs to be repeated indefinitely to maintain results.

In my view, it is more realistic to think that the damage to the epithelium, as well as the stroma and endothelium, is reduced, rather than eliminated. It might be more than acceptable after one procedure, but I wonder what the cumulative effect might be after three or four procedures.

A multicenter study is necessary to analyze the structural changes that take place within the stroma after each consecutive treatment.

— Alain Telandro, MD
OSN Europe Edition Editorial Board Member
Disclosure: Dr. Telandro has no relevant financial disclosures.