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On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.
A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcon Clareon | Active Comparator | Implantation of an intraocular lens Alcon Clareon |
|
| Hoya Vivinex | Active Comparator | Implantation of an intraocular lens Hoya Vivinex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon Clareon | Device | Implantation of an intraocular lens Alcon Clareon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PCO score | subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity) | 3 years |
| Fibrosis | grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna Allgemeines Krankenhaus | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39137100 | Derived | Leydolt C, Schartmuller D, Schwarzenbacher L, Prenner V, Danzinger V, Lisy M, Abela-Formanek C, Menapace R. Posterior capsule opacification with two similar-design hydrophobic acrylic intraocular lenses: 3-year results of a randomized controlled trial. J Cataract Refract Surg. 2024 Dec 1;50(12):1242-1246. doi: 10.1097/j.jcrs.0000000000001539. |
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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 on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
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| Hoya Vivinex |
| Device |
Implantation of an intraocular lens Hoya Vivinex |
|
| 3 years |
| Subjective glistening score | neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized | 3 years |
| YAG capsulotomy rate | described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no | 3 years |