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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 |
|---|---|---|---|
| Edof IOL vs. multifocal 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 Edof IOL one (I) vs. multifocal IOL one (I). |
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| Edof IOL vs. multifocal 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 two (II) participants will receive Edof IOL one (I) vs. multifocal IOL two (II). |
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| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Near Visual Acuity | Other outcome measure will be binocular uncorrected near visual acuity (UNVA) of each mix-and-match group. Binocular UNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
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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 |
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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.
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outcome assessor will be masked to the intraocular lens implanted.
| intraocular lens implantation | Device | 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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| D059708 | Ultrasonic Surgical Procedures |