Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL

Study Overview
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Brief Summary
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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.

Official Title
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Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL

Conditions
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Age Related Cataracts

Intervention / Treatment
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* Device: Alcon Clareon
* Device: Hoya Vivinex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned Age 50 and older Visual potential in both eyes of 20/30 or better as determined by investigators estimation Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Preceding intraocular surgery or ocular trauma Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.) Laser treatment Uncontrolled systemic or ocular disease Infectious disease Pregnancy/Nursing

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alcon Clareon<br>Implantation of an intraocular lens Alcon Clareon | Device: Hoya Vivinex<br>* Implantation of an intraocular lens Hoya Vivinex<br>|
| Active Comparator: Hoya Vivinex<br>Implantation of an intraocular lens Hoya Vivinex | Device: Alcon Clareon<br>* Implantation of an intraocular lens Alcon Clareon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCO score | subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |