Handheld FS Laser Closer to Market

Precise and reproducible anterior capsulotomies are a hallmark of femtosecond (FS) laser-assisted cataract surgery (FLACS). Yet more than a decade after its introduction, many surgeons do not take advantage of the perfectly centred and circular capsulotomies FLACS offers, often due to cost and workflow issues.

Now, a handheld FS laser designed to be more affordable, efficient, and comfortable for patients is nearing the market. A preliminary study for CE marking found it easy to use, highly effective, and safe, reported Dr Francois J Lignereux.

Frugal system

The Rx laser system (Helix Surgical) is a small-footprint, portable, battery-operated FS laser with a handheld interface for pre-cutting capsulotomies. Because it uses a curved eyepiece without suction for docking and before corneal incisions, it can be used preoperatively or in the sterile OR without disrupting surgical flow. “No time is wasted,” Dr Lignereux said.

The study involved an experienced cataract surgeon who used the device on one eye from each of the 78 cataract patients who received manual capsulorhexes in the fellow eye. The surgeon filled out a usability survey to report their feelings at different steps for each case, ranking them as very easy, rather easy, rather difficult, or difficult.

Preparation and handling were considered very easy in more than 98% of cases, reflecting the design intent to lower the operational burden of using FS capsulotomies. Visualisation through the system was considered easy in 70% of cases and very easy in 30%.

Centration was more challenging, ranking very difficult in 3% of cases, rather difficult in 35%, rather easy in 46%, and very easy in 16%, though the ratings improved with increased experience, Dr Lignereux reported. “This is due to the learning curve. Once this is over it becomes much easier.”

Once centred by looking through a reticule on the top of the laser handpiece, holding the device steadily in place during firing was considered very easy in 92% of cases.

Patients were also surveyed on their experience. They expressed no significant pain during the laser or discomfort after, with 93% reporting none for either and 7% a little pain or discomfort. Patients were also satisfied, with 89% very satisfied and 11% rather satisfied—and 90% said they would do it again.

Safe and effective

Efficacy was excellent, with continuous precuts achieved in 96% and an R2 value of 98% for circularity. Centration relative to pupil within 360 microns was achieved in all cases, suggesting that while more difficult at first, it was readily achieved. These results exceeded the study objective of achieving 95% perfect capsulorhexis, Dr Lignereux said. Refractive outcomes were excellent as well, with 96% achieving a spherical equivalent refractive outcome within 0.50 D of target.

Safety was also excellent, although problems included two cuts requiring two strokes, two uncompleted cuts, one anterior tear, and one posterior rupture unrelated to laser use. There were no reported cases of myosis, inflammation, or excess endothelial cell loss.

“This laser is based on frugality,” Dr Lignereux said. “Rx provides a solution to the contradictory conjunction between the desire for perfection and economic constraints.”

Dr Lignereux presented these findings at the 2023 ESCRS Congress in Vienna.

Francois J Lignereux MD is an ophthalmologist at the Institut Ophtalmologique Sourdille Atlantique, Nantes, France. sec.lignereux@sourdille-atlantique.fr