Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
- Conditions
- Age Related Cataracts
- Interventions
- Device: Vivinex XY1Device: Vivinex XY1A
- Registration Number
- NCT04230629
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vivinex XY1 Vivinex XY1 Implantation of an intraocular lens Hoya Vivinex XY1 Vivinex XY1A Vivinex XY1A Implantation of an intraocular lens Hoya Vivinex XY1A
- Primary Outcome Measures
Name Time Method Number of FBGC (foreign body giant cells) (slitlamp examination) 5 months The number of foreign body giant cells on the IOLs will be assessed.
- Secondary Outcome Measures
Name Time Method Incidence of Monocytes (slitlamp examination) 5 months 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
Grade of Anterior Fibrosis (slitlamp examination) 5 months Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
PCO Score (slitlamp examination) 5 months Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Anterior chamber reaction (slitlamp examination) 5 months Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)