LightTouch CK method for presbyopia shows progress in FDA trials

The conductive keratoplasty technique is surpassing FDA guidelines in prospective clinical trials, according to an investigator.

Issue: July 1, 2006

ByKatrina Altersitz

Preliminary prospective clinical trial data on LightTouch CK, a currently off-label method of performing conductive keratoplasty, are promising, according to one surgeon involved in the studies.

Henry L. “Rick” Milne, MD, presented the 1-month results of the first 93 eyes in clinical trials for Food and Drug Administration approval of the LightTouch procedure at the American Society of Cataract and Refractive Surgery meeting earlier this year.

“I think it’s a very essential part of our refractive practice,” Dr. Milne told Ocular Surgery News in an interview after the meeting. “There are so many patients that come in, and this is their best option as an entry point to refractive surgery.”

Clinical trials

Although many refractive surgeons already use the LightTouch technique for conductive keratoplasty (CK) with the Refractec NearVision CK system, the technique is still considered off-label and has been in need of thorough prospective evaluation, Dr. Milne said.

“It is the common way that CK is being performed, but there really has not been a good prospective study,” he said in the presentation. “Everything has been retrospective.”

This prospective, multicenter study will eventually include 125 eyes of 125 patients who will receive LightTouch on their nondominant eye.

In the first 93 patients, the 1-month results have surpassed guidelines set by the FDA, Dr. Milne said.

He reported that 66% of patients are within 0.5 D of their intended target refraction, and 88% are within 1 D; 88% of patients can read J1 at near, and 97% are J3 or better.

“That’s really, really good numbers there,” he said in his presentation. He told OSN that all of the 125 patients have been recruited and treated, and the earliest patients are approaching the 1-year follow-up point.

“We should have that data completed by the first or second quarter of next year,” he said.

Importance of LightTouch

Dr. Milne reiterated the importance of this refractive procedure for patients – natural and LASIK plano presbyopes and IOL patients – as well as its effectiveness and safety.

“It does the least to their eyes,” he told OSN. “They get back more near vision, giving up less distance vision than any other procedure that we can offer.”

Dr. Milne has seen “hyperopic surprise” occur in multifocal patients on whom he then performed LightTouch CK.

“It took both patients from being dissatisfied to being extremely happy with their postop vision just by doing CK,” he said. “They’re two of my happiest patients now. It’s a really nice rescue procedure for multifocal implants.”

After LightTouch, spectacle independence greatly improves, Dr. Milne said in his presentation, allowing patients to see everything from street signs to fine print.

“Most subjects rarely or never use glasses at any distance and had a significant change in spectacle dependence in near (vision),” he said.

In addition, Dr. Milne said that he has seen no serious complications thus far in the clinical trials. He said the only complications were induced cylinder and infection, which was rarely seen.

Induced cylinder is “easily addressed in the situation by just going back to the place where you got less response and putting additional treatment,” he said.

Overall, he said the clinical studies are not surprising, and the results support his own experiences with the LightTouch procedure.

“It is a very safe event. … Accuracy is well above FDA targets. Binocular distance has been maintained,” Dr. Milne said. “Patient satisfaction rate is very high at 93% satisfied or very satisfied.”

For more information:

Henry L. “Rick” Milne, MD, can be reached at The Eye Center, 1655 Bernardin Ave., Suite 100, Columbia, SC 29204; 803-256-0641; e-mail: hmilne@aol.com.

Katrina Altersitz is an OSN Staff Writer who covers all aspects of ophthalmology.