Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Vivinex XY1 Implantation of an intraocular lens Hoya Vivinex XY1 |
Device: Vivinex XY1
Implantation of an intraocular lens Hoya Vivinex XY1
|
Active Comparator: Vivinex XY1A Implantation of an intraocular lens Hoya Vivinex XY1A |
Device: Vivinex XY1A
Implantation of an intraocular lens Hoya Vivinex XY1A
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
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Age 40 and older
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Astigmatism of at least 0.75Diopters in one eye
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Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
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Diabetes mellitus
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Pseudoexfoliation syndrome
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Systemical anticoagulation
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Antiphlogistic therapy
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Antiglaucomatosa
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Uncontrolled systemic or ocular disease
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Preceding ocular surgery or trauma
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Intraoperative complications
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Pregnancy/Nursing
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Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2060/2019