Age Related Cataracts
Conditions
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.
Interventions
DEVICEVivinex XY1
Implantation of an intraocular lens Hoya Vivinex XY1
DEVICEVivinex XY1A
Implantation of an intraocular lens Hoya Vivinex XY1A
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
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 |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
| Anterior chamber reaction (slitlamp examination) | 5 months | Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively) |
Contacts
Primary ContactRupert Menapace
Outcome results
None listed