EDOF and Multifocal IOL Study

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 and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial

Conditions
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Age-related Cataract

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


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 50-90 Visual potential in both eyes of 20/30 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 ocular surgery or trauma Relevant other ophthalmic diseases (such as retinal degenerations, etc.) Uncontrolled systemic or ocular disease

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intra-individual comparison of two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edof IOL vs. multifocal 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 Edof IOL one (I) vs. multifocal IOL one (I). | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation<br>Device: intraocular lens implantation<br>* intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification<br>|
| Experimental: Edof IOL vs. multifocal 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 two (II) participants will receive Edof IOL one (I) vs. multifocal IOL two (II). | Procedure: phacoemulsification and intraocular lens implantation<br>* bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation<br>Device: intraocular lens implantation<br>* intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distant corrected near visual acuity | Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. | 6 months |