Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

Study Overview
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Brief Summary
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On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH. A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.

Official Title
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Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

Conditions
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Age Related Cataracts

Intervention / Treatment
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* Device: Vivinex XY1
* Device: Vivinex XY1A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 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 on subjects and includes: visual acuity, slitlamp examination.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vivinex XY1<br>Implantation of an intraocular lens Hoya Vivinex XY1 | Device: Vivinex XY1<br>* Implantation of an intraocular lens Hoya Vivinex XY1<br>|
| Active Comparator: Vivinex XY1A<br>Implantation of an intraocular lens Hoya Vivinex XY1A | Device: Vivinex XY1A<br>* Implantation of an intraocular lens Hoya Vivinex XY1A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of FBGC (foreign body giant cells) (slitlamp examination) | The number of foreign body giant cells on the IOLs will be assessed. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Monocytes (slitlamp examination) | The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2 | 5 months | 
| PCO Score (slitlamp examination) | Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO) | 5 months | 
| Grade of Anterior Fibrosis (slitlamp examination) | Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis) | 5 months | 
| Anterior chamber reaction (slitlamp examination) | Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively) | 5 months |