Cataract
Conditions
Keywords
Biocompatibility
Brief summary
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
Interventions
PROCEDUREcataract surgery
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (XY1) vs. an toric IOL (XY1A)
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Intra-individual comparison of the biocompatibility of two different IOLs. Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the eye with no astigmatism and the other IOL type in the eye with astigmatism.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned * Age 40 and older * Astigmatism of at least 0.75Diopters in one eye * Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion criteria
* Diabetes mellitus * Pseudoexfoliation syndrome * Systemical anticoagulation * Antiphlogistic therapy * Antiglaucomatosa * Uncontrolled systemic or ocular disease * Preceding ocular surgery or trauma * Intraoperative complications * Pregnancy/Nursing * Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foreign Body Giant Cells | 6 weeks | The primary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 6 weeks follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foreign Body Giant Cells | 5 months | The first secondary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 1 week and 5 months follow up. |
| small round cells | 5 months | The second secondary objective is to assess the difference in small round cells between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up. |
| PCO | 5 months | The third secondary objective is to assess the difference in PCO between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up. |
| anterior chamber reaction | 5 months | The fourth secondary objective is to assess the difference in the anterior chamber reaction between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up. |
Countries
Austria
Outcome results
None listed