Clinical Investigation to evaluate user experience with the CATALYS Precision Laser System cOS 6.0
- Conditions
- h25H26Senile cataractOther cataract
- Registration Number
- DRKS00020773
- Lead Sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 47
• Minimum 22 years of age
• Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned
• Availability, willingness, sufficient cognitive awareness to comply with examination procedures
• Clear intraocular media other than cataract
• At least 0.5D of corneal cylinder (measured by Cassini or other keratometer or corneal topographer for which arcuate corneal incisions or use of toric IOL are planned
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.
• Any condition in the study eye which, in the Investigator's opinion, would confound the study results.
• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Concurrent participation or participation in any other interventional clinical trial during the duration of this clinical study including 30 days prior to study visit
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall clinical acceptability” will be calculated as the average score of the surgeon’s ratings for the following five questions on a five point rating scale* for each treated eye:<br>o Satisfaction with import of preop diagnostic data<br>o Satisfaction with automated input of arcuate incision parameter into treatment plan<br>o Satisfaction with Iris registration<br>o Satisfaction with steep meridian marking<br>o Overall rating of satisfaction with workflow
- Secondary Outcome Measures
Name Time Method Rate of complications and adverse events