Intraindividual Comparison of EMO IOLs

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

Conditions
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Age Related Cataracts

Intervention / Treatment
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* Procedure: phacoemulsification and intraocular lens implantation
* Procedure: phacoemulsification and intraocular lens implantation
* Procedure: phacoemulsification and intraocular lens implantation
* Procedure: phacoemulsification and intraocular lens implantation
* Procedure: phacoemulsification and intraocular lens implantation
* Procedure: phacoemulsification and intraocular lens implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation Age 50 to 100 Visual potential in both eyes of 20/25 or better as determined by investigators estimation Normal findings in 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 that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma) Pupil diameter < 2.0 mm (photopic) Laser treatment Uncontrolled systemic or ocular disease Pregnancy/Nursing childbearing ability

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intra-individual comparison of 5 groups receiving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monofocal IOL I vs. enhanced monofocal IOL I<br>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 (ZCB00) vs. an enhanced monofocal IOL (ICB00) | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)<br>|
| Experimental: Monofocal IOL II vs. enhanced monofocal IOL I<br>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 two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00) | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00)<br>|
| Experimental: Monofocal IOL III vs. enhanced monofocal IOL II<br>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 three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress). | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress)<br>|
| Experimental: Enhanced monofocal IOL II vs. enhanced monofocal IOL II<br>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 four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes<br>|
| Experimental: Monofocal IOL III vs. enhanced monofocal IOL IV<br>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 five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart) | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)<br>|
| Experimental: Enhanced Monofocal IOL V vs. enhanced monofocal IOL V with irregular astigmatism<br>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 five (VI) participants will receive an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed. | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant corrected intermediate visual acuity | Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. | 2-6 months | 
| Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL | Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted and eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. | 3-5 months |