The First Usability Feedback Of A New Hand-Held Femtosecond Laser For Assisted Capsulorhexis In Cataract Surgery

The aim of this trial is to share first Rx Laser experience and first return about usability and patient’s feedback. Despite the introduction of FLACS 14 years ago and mainly because workflow and cost effectiveness issues, the standard of care to perform capsulorhexis remains manual. An innovating new hand-held femtosecond laser (Rx Laser by Helix Surgical - Ilasis, Bordeaux, FR) will be launch soon to combine manual ability of the surgeon with safety and predictability of an affordable femtosecond technology. The first feasibility study on human was finalized on March 2023. Cutting performances, usability, and patient’s feedback have been investigated in a second set of analysis.

Some usability aspect of the Rx laser system by Helix Surgical were evaluated in Institut Ophtalmologique Sourdille Atlantique (Nantes,FR) : the preparation of Rx Laser, handling, visualization through the system, centration, laser shoot, holding the position during laser shoot. At the end of the procedure, the patient was asked for any discomfort while and after Laser.

From February 2022 to March 2023, 78 patients had a cataract surgery with Helix Rx with 1 week and 30 days follow-up. Only one eye was treated with the laser and the other one manually. it was an interventional, prospective, longitudinal, single-arm, monocentric and open trial. A usability survey was filled by the surgeon to report his feeling at different steps, ranking them as: very easy, easy, rather easy, rather difficult, or difficult. 

The Rx laser was perfectly suitable and mobile into the operating room. Since eye is not open and there is no suction (i.e. no hemorrhage), the Rx laser can also be used in pre-operating room. The preparation is easy and handling was considered very easy in more than 98% of the cases. Visualization through the system remains easy (70%) or very easy (30%). Centration was considered as 3% very difficult, 35% rather difficult, 46%rather easy and 16% very easy but became clearly easier with increased expertise. Rx was considered very easy for holding the position during laser fire (92%). No significant pain during the laser or discomfort after was felt by the patient (both = none 93% and low 7%). Patients were satisfied (very 89% rather 11%).

Getting started with Helix Rx is fast and makes it easy to get a perfectly circular 5 mm capsulorhexis without any safety issue in hands of one experimented surgeon. It takes less than 10 cases to have it perfectly centered and to get a good control of the visualization system and orientation of the handpiece. Further studies will be necessary to confirm that trend in less experimented hands.