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| ID | Type | Description | Link |
|---|---|---|---|
| 2060/2019 | Other Identifier | Medical University of Vienna - Ethic Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric vs Monofocal IOL | Other | 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. In Arm one (I) participants will receive a monofocal IOL (XY1) vs. an toric IOL (XY1A) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Foreign Body Giant Cells | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Foreign Body Giant Cells | 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. | 5 months |
| small round cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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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.
| 5 months |
| PCO | 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. | 5 months |
| anterior chamber reaction | 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. | 5 months |