Study Results
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Basic Information
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RECRUITING
NA
461 participants
INTERVENTIONAL
2021-12-13
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Monofocal IOL I vs. enhanced monofocal 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 a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
phacoemulsification and intraocular lens implantation
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)
Monofocal IOL II vs. enhanced monofocal 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 two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)
phacoemulsification and intraocular lens implantation
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)
Monofocal IOL III vs. enhanced monofocal 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 three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).
phacoemulsification and intraocular lens implantation
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)
Enhanced monofocal IOL II vs. enhanced monofocal 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 four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target
phacoemulsification and intraocular lens implantation
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
Monofocal IOL IV vs. enhanced monofocal IOL III
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)
phacoemulsification and intraocular lens implantation
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)
Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatism
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.
phacoemulsification and intraocular lens implantation
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
Extended Depth of Focus IOL in eyes with irregular astigmatism
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.
phacoemulsification and intraocular lens implantation
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
Monofocal IOL IV vs. enhanced monofocal IOL IV
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)
phacoemulsification and intraocular lens implantation
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)
Enhanced depth of focus IOL I vs. Enhanced depth of focus 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 nine (IX) participants will receive an enhanced depth of focus IOL (PureSee) bilateral with a monovision target.
phacoemulsification and intraocular lens implantation
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
Monofocal IOL VI and monofocal IOL III
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
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
Interventions
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phacoemulsification and intraocular lens implantation
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
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
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
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
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
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
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
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
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
phacoemulsification and intraocular lens implantation
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)
* postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X))
* Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))
Exclusion Criteria
* 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
50 Years
100 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Christina Leydolt
Assoc. Prof. PD Dr
Principal Investigators
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Christina Leydolt, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1631/2021
Identifier Type: -
Identifier Source: org_study_id
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