EDOF and Multifocal IOL Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Edof IOL vs. multifocal IOL I 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
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation
Device: intraocular lens implantation
intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification
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Experimental: Edof IOL vs. multifocal IOL II 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
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation
Device: intraocular lens implantation
intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification
|
Outcome Measures
Primary Outcome Measures
- distant corrected near visual acuity [6 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
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Age 50-90
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Visual potential in both eyes of 20/30 or better as determined by investigators estimation
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Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
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Preceding ocular surgery or trauma
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Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
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Uncontrolled systemic or ocular disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1163/2020