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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofocal IOL I vs. enhanced monofocal IOL I | Experimental | 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) |
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| Monofocal IOL II vs. enhanced monofocal IOL I | Experimental | 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) |
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| Monofocal IOL III vs. enhanced monofocal IOL II | Experimental | 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). |
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| Enhanced monofocal IOL II vs. enhanced monofocal IOL II | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phacoemulsification and intraocular lens implantation | Procedure | 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) |
| 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, IC-8 Apthera IOL | Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in 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 |
| Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1 | Primary outcome measures for arm ten (X) will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions | 2-6 months and 1-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity and reading ability | Secondary outcome measures will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions. | 2-6 months and 1-5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Leydolt, MD | Contact | +43 (01) 40 400 79480 | christina.leydolt@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Christina Leydolt, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | Austria |
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Intra-individual comparison of 7 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.
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outcome assessor will be masked to the intraocular lens implanted
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| Monofocal IOL IV vs. enhanced monofocal IOL III | Experimental | 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) |
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| Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatism | Experimental | 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 six (VI) participants will receive an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed. |
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| Extended Depth of Focus IOL in eyes with irregular astigmatism | Experimental | 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 seven (VII) participants will receive an extended depth of focus IOL (IC-8 Apthera IOL) in one eye if irregular astigmatism is observed. |
|
| Monofocal IOL IV vs. enhanced monofocal IOL IV | Experimental | 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 eight (VIII) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire) |
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| Enhanced depth of focus IOL I vs. Enhanced depth of focus IOL I | Experimental | 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 nine (IX) participants will receive an enhanced depth of focus IOL (PureSee) bilateral with a monovision target. |
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| Monofocal IOL VI and monofocal IOL III | Experimental | 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 ten (X) participants will receive a monofocal IOL (Vivinex XC1) bilateral or a monofocal IOL (Vivinex XY1) bilateral. |
|
| phacoemulsification and intraocular lens implantation | Procedure | 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) |
|
| phacoemulsification and intraocular lens implantation | Procedure | 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) |
|
| phacoemulsification and intraocular lens implantation | Procedure | 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 |
|
| phacoemulsification and intraocular lens implantation | Procedure | 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) |
|
| phacoemulsification and intraocular lens implantation | Procedure | bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed |
|
| phacoemulsification and intraocular lens implantation | Procedure | bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (IC-8 Apthera) in one eye if irregular astigmatism is observed |
|
| phacoemulsification and intraocular lens implantation | Procedure | bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire) |
|
| phacoemulsification and intraocular lens implantation | Procedure | bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced depth of focus IOL (PureSee) in both eyes |
|
| phacoemulsification and intraocular lens implantation | Procedure | bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) in both eyes or a monofocal IOL (Vivinex XC1) in both eyes |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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