Femtosecond laser procedure effectively treats presbyopic emmetropes

Results of a new femtosecond laser treatment for presbyopia show improvement in near visual acuity in a procedure that lasts less than 20 seconds.

Mike P. Holzer

The IntraCor intrastromal femtosecond laser correction procedure effectively and safely treated presbyopic emmetropes, a small subset study found.

“We have here a procedure for a group of patients where, so far, no other alternative treatment was really possible in order to treat them for presbyopia,” Mike P. Holzer, MD, told Ocular Surgery News in a telephone interview. “You could think of doing a refractive lens exchange procedure and implant an accommodating or multifocal IOL. However, as a surgeon, when the patient has not any refraction for distance, you are a little bit hesitant to do intraocular surgery. … This is now a new procedure that focuses on emmetropes to treat them for presbyopia.”

Dr. Holzer and colleagues at the International Vision Correction Research Centre at the University of Heidelberg, Germany, studied 25 presbyopic emmetrope patients who underwent the IntraCor procedure with the Technolas Femtosecond Workstation laser (Technolas Perfect Vision). The study is part of an ongoing multicenter European trial.

The IntraCor procedure produced a significant near visual acuity gain in presbyopic emmetropes that did not impair distance vision or cause complications, according to Dr. Holzer.

“The new femtosecond laser-based IntraCor treatment of presbyopia is a fast procedure that leads to a significant near visual acuity gain with stable results over a 1-year period,” Dr. Holzer and colleagues said in an abstract presented at the European Society of Cataract and Refractive Surgeons meeting in Barcelona, Spain.

Results

The prospective clinical study examined the surgical and functional outcomes of the IntraCor procedure. Main outcome measures were distance and near visual acuity. Endothelial cell count, corneal topography and wavefront aberration measurements were also taken and correlated to the visual acuity outcomes.

The study found no difference in preop or postop endothelial cell count. Following surgery, corneal topography showed central steeping of the cornea.

Dr. Holzer said visual acuity outcomes were stable at 3 months postoperatively. Preoperative mean near uncorrected visual acuity was 0.70 ± 0.16 logMAR. At 6 months postop, it had improved to 0.27 ± 0.24 logMAR. By 1 year, results were similar.

“The patients had already a significant increase in near visual acuity on the first day. But starting at 3 months, there was really no change at all,” he said. “They gain very fast in the near visual acuity and therefore, at the moment, we can say that this is a new procedure with a very high potential to be an important treatment option for future patients.”

He cautioned that long-term follow-up is needed to ensure results continue at 5 years and 10 years postop. The procedure now has up to 2 years of follow-up on patients initially treated by Luis Ruiz, MD, who performed the first IntraCor treatment and so far has performed the most.

Complications

Currently, there is no regression or corneal weakening evident in patients, Dr. Holzer said.

Complications were limited, but some patients in the study underperformed with lower visual results than others. Underperformance should be addressed to determine why some patients have better results, and a patient profile should also be established, Dr. Holzer said.

“At the moment, we are looking at refractions, but maybe there are many factors involved that we would need to test before in order to find the best candidates for this procedure,” he said.

Benefits of procedure

Dr. Holzer said one of the main benefits of the procedure is its noninvasive structure technique. The procedure treats the cornea from the outside, with a laser beam that is placed in the correct depth of the cornea.

“I think it’s a step forward doing refractive changes, or biomechanical changes to the cornea, from [the] outside, without opening the cornea, just by applying a laser to the middle of the cornea and doing some tiny changes there that affect the refraction,” he said.

Another benefit of the procedure is its fast treatment time, he said. In the study, mean treatment time was less than 20 seconds. The procedure can take from 15 seconds to 20 seconds to perform a pure presbyopic treatment. The procedure’s noninvasive laser technique also promotes a quick recovery for patients and minimal infection or inflammation risk, he said.

“Doctors all over the world are very interested, listening to the talks and asking lots of important questions,” Dr. Holzer said. “I think we need some time just to figure out how all of that works, and we’re just at the beginning.”

While the IntraCor procedure currently focuses on emmetropes or low hyperopes, Technolas Perfect Vision is evaluating expanding the indications to a broader patient population. – by Erin L. Boyle

• Mike P. Holzer, MD, can be reached at International Vision Correction Research Centre, University of Heidelberg, Department of Ophthalmology, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; 49-6221-566999; fax: 49-6221-568229; e-mail: mike.holzer@med.uni-heidelberg.de. Dr. Holzer is a paid consultant for Technolas Perfect Vision, who sponsored the study discussed in this article.