Actively Recruiting
Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
Led by Helix Surgical · Updated on 2026-01-30
446
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Helix Surgical
Lead Sponsor
S
Santé Atlantique - Saint-Herblain - France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the rate of capsular ruptures during cataract surgery using a handheld femtosecond laser called Rx. This observational study aims to confirm if the rupture rate with Rx use is lower than 2%, supplementing data collected in a previous pre-market investigation. The study is conducted at a single center and follows patients prospectively for about 30 days after surgery. The study includes one group of patients undergoing cataract surgery with the Rx laser used as intended. The device is designed to assist in performing the anterior capsulotomy during surgery. The study uses a sequential design with up to 446 patients to monitor the rate of capsule ruptures. Interim analyses determine if the rupture rate meets success or failure criteria, potentially stopping the study early if clear results are found. Participants will have their medical records reviewed and will be followed for approximately 30 days after surgery to assess outcomes. Researchers will monitor the rate of capsule ruptures during surgery, the continuity of the capsulorhexis, and any adverse device effects immediately during surgery and at about 4 days and 30 days post-surgery. This study helps evaluate the safety of using the Rx laser in routine cataract surgery.
CONDITIONS
Brief Title
Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (age > 18 years)
- Diagnosed with cataract requiring surgery according to current guidelines
- Eligible for lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia
- Confirmed their non-opposition to data collection
You will not qualify if you...
- Patient already operated with Rx for the first eye
- Any contra-indication to cataract surgery
- Anterior Chamber Depth less than 1.8mm or greater than 4.2mm
- Corneal disease or pathology preventing corneal applanation or interfering with laser beam transmission
- Presence of blood or other elements hindering light propagation between epithelium and lens
- Weak pupil dilation or severely off-center pupil preventing adequate iris retraction (dilations < 6.5mm)
- Abnormal tilt of the lens (> 7 degrees)
- Significant preoperative ocular hypotonia or hypertonia
- Presence of an intra-corneal implant
- Active or unstabilized ocular surface disease including abnormal corneas
- History of lens disease or zonular instability
- Any perforating incision of the eyeball causing leakage during corneal applanation
- Presence of a limbal tumor obstacle hindering device stabilization
- Patients under guardianship, trusteeship, or deprived of liberty
- Patients unable to give non-opposition for data collection due to psychiatric, cognitive, or linguistic reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cataract surgery using a handheld femtosecond laser for anterior capsulotomy. Device performance and safety are assessed during surgery and shortly after.
1 surgical visit (in-person) and 1 post-operative visit within 4 ± 2 days
Duration - Approximately 30 days
Participants are followed for safety and device effects for approximately 30 ± 15 days after surgery.
1 follow-up visit approximately 30 ± 15 days after surgery
Trial Site Locations
Total: 1 location
1
Santé Atlantique
Saint-Herblain, France
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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