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
109 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
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.
CONDITIONS
Official 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
- Provided consent for data collection
You will not qualify if you...
- Patient already operated with Rx for the first eye
- Any contraindication 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 any other element hindering light propagation between the epithelium and lens
- Weak pupil dilation or severely off-center pupil preventing iris retraction (dilation < 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 that may interfere with device stabilization
- Patients under guardianship, trusteeship, or deprived of liberty
- Patients unable to consent to data collection due to psychiatric, cognitive, or linguistic reasons
AI-Screening
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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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