The goal of this observationnal study is to supplement the data collected in the pre-market study and confirm the rate of capsular ruptures due to Rx (reducing its related confidence interval).
During cataract surgery, an artificial lens is placed into the capsular bag. The main question this study aims to answer is :
Is Rx use associated with a rate of caspular ruptures lower than 2% ? Medical records of participants having cataract surgery with Rx laser as part of their regular medical care will be assessed in order to answer the study objective.
Adult patients (age > 18 years);
Diagnosed with cataract requiring surgery according to current guidelines;
Eligible to lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia;
Who confirmed their non-opposition to data collection
Patient already operated with Rx for the first eye.
Any contra-indication to cataract surgery;
Patients with an ACD (Anterior Chamber Depth) less than 1.8mm and greater than 4.2mm;
Corneal disease or pathology that prevents corneal applanation or that may interfere with or hinder laser beam transmission;
Adult patients eligible for cataract surgery
Other
Prospective
Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy (CE-marked device used as intended)
DeviceCataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy
Rate of capsule-ruptures due to Rx
The investigator considers a rupture of the capsule will be Rx-related if: * There are peripheric tears that can generate the rupture of the capsule during or at the end of rhexis removal; * AND these tears generate the rupture of the capsule during surgery.
Continuity of the capsulorhexis (success / failure)
Success is achieved if: * the anterior capsule is completely cut (rhexis is free floating or easy to remove) * AND there are no peripheric tears that can generate the rupture of the capsule at the end of rhexis removal.
Adverse device effects
Collection of adverse device effects by the investigator on the retina, on the cornea, on the posterior capsula and other adverse device effects
Patient's perception about Rx use (exploratory endpoint)
Patient's rating, on a 4-degree-scale of discomfort, and overall satisfaction with the use of Rx
Rx usability (exploratory endpoint)
o Investigator's rating, on a 4-degree-scale of several surgical steps: preparing the device before surgery; handling the device in the operating field; visualizing the eye through the device; centering the device on the capsule; keeping the device in the correct position; activating the laser beam; removing the device from the eye after capsulorhexis, etc. o Measure of laser power delivered by Rx before each surgery.
Circularity of the capsulorhexis (exploratory endpoint)
Ratio : real capsulorhexis surface in mm2 / intended capsulorhexis surface in mm2
Distance between the center of the rhexis and the center of the pupil / iris (in mm) (exploratory endpoint)
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Helix Surgical
Lead sponsor
Santé Atlantique - Saint-Herblain - France
Collaborator
