Post-Market Clinical Follow-Up Study Evaluating Safety and Performance of HOYA IOLs in Routine Practice
- Conditions
- Senile cataractH25
- Registration Number
- DRKS00012740
- Lead Sponsor
- HOYA Surgical Optics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 784
Inclusion Criteria
1. Minimum 22 years of age
2. Planned natural lens replacement with posterior chamber IOL implantation
3. Available and comply to study procedures
4. Ability and willingness to sign informed consent
Exclusion Criteria
1. Participation in this PMCF with the other eye.
2. 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
3. Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial with an investigational product
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual acuity at visit 1 week, 6 weeks, 6 months, 1 year, 2 years, 3 years;<br>measured with Visual acuity charts at a minimum distance of 4 meter<br>
- Secondary Outcome Measures
Name Time Method 1. Device related adverse events (ADEs and SADEs)<br>2. Number of capsulotomies <br>3. Subjective Posterior Capsular Opacification-grading in slit lamp examination at each visit<br>4. Subjective grading of glistening, density of glistening is determined at the slit lamp<br>5. Subject questionnaires for visual symptoms and satisfaction at each visit<br><br>