'FDA approves OptiMedica system

Key Points

Santa Clara, CA-The field of laser cataract surgery continues to evolve with the Dec. 22 announcement by OptiMedica that its proprietary laser system (Catalys Precision Laser System) received FDA 510(k) market clearance for capsulotomy and lens fragmentation.

One of the most important components of cataract surgery is creation of the continuous circular capsulorhexis. However, it is also one of the most difficult maneuvers to perform and requires exceptional surgical expertise to achieve a well-centered opening.

Dr. Culbertson and colleagues evaluated the laser system first in 46 porcine eyes and later in a prospective, randomized human trial of 39 patients conducted in the Dominican Republic. The investigators published the results in the Journal of Cataract and Refractive Surgery (2011;37:1189-1198).

A manual capsulorhexis was created in 13 porcine eyes and a laser capsulotomy was performed in 33 porcine eyes. When the mean strength of the capsule was assessed using a capsule-stretching instrument, the results suggested that "a laser- created capsulotomy may be more than twice as strong as a capsulorhexis created manually," the investigators reported. The mean strength decreased with increasing pulse energy (i.e., 152 ± 21 mN with 3 mJ, 121 ± 16 mN with 6 mJ, and 113 ± 23 mN with 10 mJ). The manual capsulorhexes had a mean strength of 65 ± 21 mN.

In the 39 patients, one eye of each patient underwent laser-assisted capsulotomy and the fellow eye of 24 of the patients was the control in which manual cataract surgery was performed. The investigators reported, "The laser capsulotomy cuts were complete, with no radial nicks or tears, and no complications attributable to the laser treatments occurred."

Precise size, shape

Dr. Culbertson and colleagues found that the laser-created capsulotomies were "significantly more precise in size and shape than manually created capsulorhexes."

In the patients' eyes, the laser-created capsulotomies deviated very little from the intended diameter of the resected capsule disk (mean, 29 ± 26 µm) compared with a large mean deviation (337 ± 258 µm) for the manual technique. The mean deviations from circularity were 6% and 20%, respectively. The center of the laser-created capsulotomies was within a mean of 77 ± 47 µm of the intended position.

In a previous study of the system (Palanker D. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Science Translational Medicine. 2010;2:1-9), the authors reported, "Laser lens fragmentation with Catalys has also been shown to reduce by approximately 40% the amount of ultrasound energy needed during phacoemulsification (cataract break-up, irrigation, and extraction)."

The authors concluded that "Catalys delivers unparalleled improvements in precision and ease of lens disassembly. The data showed that the system is able to produce capsulotomies that are within 30 µm of intended size and 80 µm of intended center, with near perfect circularity." "The reproducible precision of the capsulotomy and corneal incisions with their potential for innovative IOL designs coupled with the reduction or even possibly the complete elimination of phacoemulsification to remove the cataract nucleus portends a bright new future for the outcomes of cataract surgery," Dr. Culbertson said.

FYI

William W. Culbertson, MD
E-mail: wculbertson@med.miami.edu

The authors reported having equity interest in OptiMedica Corp. Catalys was CE mark approved in August 2011 and has since been shipped to leading ophthalmic centers outside the United States.