New laser is designed to deliver low-energy treatment with ultrashort pulse duration.
Reviewed by Mahipal Sachdev, MD
The ELITA Femtosecond Laser System (Johnson & Johnson Surgical Vision), a new investigational laser, received FDA 510(k) clearance in April 2023 for the creation of corneal flaps during laser-assisted in situ keratomileusis (LASIK) procedures.
This new laser is designed to deliver low-energy treatment with ultrashort pulse duration, ultrafast pulse frequency, small focus spot size, faster and smoother cuts, and less stromal disruption. The advantages of this laser, according to the company, are that patient outcomes will improve with increased vision, reduced complications, and fast visual recovery.
An early feasibility study was designed to determine the accuracy of the Elita Femtosecond Laser compared with the IntraLase Femtosecond Laser (iFS; Abbott Medical Optics) in creating the corneal flaps. Mahipal Sachdev, MD, from the Centre for Sight Eye Institute in New Delhi, India, shared the results of the early clinical experience with the laser.
A prospective, single-center, open-label, randomized clinical study was conducted at the Centre for Sight Eye Institute with the goal of evaluating the accuracy of the flap thickness using the new laser. Both eyes of 50 patients were included. The Elita Femtosecond Laser was used to create the flap in the study eye and the iFS created the flap in the fellow eye of each patient, Sachdev recounts.
All flaps were planned to be 110 μm. The flap thickness was measured on anterior segment optical coherence tomography (AS-OCT) scans that were obtained 1 week, 1 month, and 3 months after LASIK procedure.
An average of 3 AS-OCT measurements of flap thickness and SD were compared between the flaps created by the 2 lasers. The investigators also evaluated the correlations between the baseline corneal pachymetry and mean keratometry values and flap thickness at 1 week, 1 month, and 3 months after LASIK.
Sachdev reported that the difference between the achieved flap thicknesses with the new femtosecond laser system and the iFS was statistically significant (P ≤ .01 for all visits). Both systems were consistent, with an SD value of plus or minus 5.6 μm for the new laser and plus or minus 6.5 μm for the iFS at the 3-month measurements.
The variability of both systems was similar. The mean achieved flap thicknesses of the Elita Femtosecond Laser and the iFS, respectively, were 109.9 μm and 122.9 μm at 1 week after the operation, 110.7 μm and 124.7 μm at 1 month, and 110.9 μm and 122.8 μm at 3 months. No correlation was found between the baseline corneal thickness or mean keratometry and achieved flap thickness, with R2 values below 0.07 for both parameters at all time points, Sachdev explained.
The conclusions from the study were that the early feasibility study findings demonstrated the “excellent accuracy” of the Elita Femtosecond Laser compared with the iFS in creating flaps for LASIK procedures. Both systems achieved consistent flap thicknesses with similar variability over time.
“A combination of ultrashort pulse duration, ultrafast pulse frequency, small focus spot size, [and] less stromal disruption gives minor or no tissue adhesions,” Sachdev said. “None of the cases had any difficulty with flap dissection; the plane identification was very easy.”
Moreover, Sachdev points out that corneal biomicroscopy was unremarkable on day 1. “All eyes had fast visual recovery and accurate refractive correction,” he concluded. “The overall patient satisfaction was great.”
The Elita Femtosecond Laser will be available to ophthalmologists across the United States later in 2023.