H25
Conditions
Interventions
Group 1: Collect and evaluate long-term clinical data on safety and performance of actual registered and marketed HOYA Surgical Optics IOLs within the duration of the study.
Sponsors
HOYA Surgical Optics GmbH
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity at visit 1 week, 6 weeks, 6 months, 1 year, 2 years, 3 years; measured with Visual acuity charts at a minimum distance of 4 meter | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device related adverse events (ADEs and SADEs) 2. Number of capsulotomies 3. Subjective Posterior Capsular Opacification-grading in slit lamp examination at each visit 4. Subjective grading of glistening, density of glistening is determined at the slit lamp 5. Subject questionnaires for visual symptoms and satisfaction at each visit | — |
Countries
Austria, Belgium, France, Germany, Netherlands, Spain
Contacts
Public ContactNorbert Clemens, MD
HOYA Surgical Optics GmbH
Outcome results
None listed