First Results Of A New Hand-Held Femtosecond Laser To Perform Anterior Capsulorhexis For Cataract Surgery

Since the early 2010’ femtosecond Lasers have been introduced to assist the cataract surgeries by doing automatically corneal incisions, capsulorhexis and lens fragmentation. The “Helix Rx” capsulotome is a new femtosecond Laser technology introduced by Ilasis Laser™ who was optimized to perform exclusively the capsulorhexis within few milliseconds. Therefore, Rx device is foreseen to deliver similar performances as other femtosecond laser systems available but enhancing workflow, cost-effectiveness and usability. The purpose of our study was to analyze safety and efficacy of the Helix Rx laser assisted capsulorhexis in a group of patients planned for conventional cataract surgery.

Clinique Sourdille Atlantique, Nantes, farnce

This first clinical study was designed as interventional, monocentric, prospective study, involving one unique and experimented surgeon. The Helix Rx Laser capsulotome performance and safety to make a 5 mm round and centered capsulorhexis in the routine cataract workflow was analyzed at one week and one month post operatively. 78 eyes of 78 consecutive patients were involved for cataract surgery assisted by Rx capsulorhexis from February to March 2023. The five first patients were included in the safety set (learning curve).

The efficacy of Rx was confirmed in 70 out of the 73 patients of the performance set (95,9%). Indeed, the 3 eyes in failure were due for 2 to a primary device deficiency to fire (prototype damaged during transport) and for one to a usability issue (handpiece misalignment by the operator). The 3 patients in failure were the first eyes of the performance set. All other following Laser procedures were successfully achieved. Thus, Rx performance of was confirmed in 70 out of 71 patients of the performance set (98,6%). For the safety standpoint, no capsular tear or rupture was induced by Rx. No significant adverse event was described per-operatively and at one month of follow up.

If we don’t consider machine failure that didn’t induced adverse, a success rate of 98,6% was reached for the primary endpoint and despite a very new innovating approach.  The Helix Rx Laser handpiece ergonomics exhibited a very short learning curve in this first feasibility study.