RecruitingNot ApplicableNCT05822089

Intraindividual Comparison of EMO IOLs

Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses


Sponsor

Medical University of Vienna

Enrollment

461 participants

Start Date

Dec 13, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 100 Years

Inclusion Criteria7

  • Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
  • 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 Criteria7

  • Preceding intraocular surgery or ocular trauma
  • 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

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Interventions

PROCEDUREphacoemulsification 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)

PROCEDUREphacoemulsification 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)

PROCEDUREphacoemulsification 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)

PROCEDUREphacoemulsification 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

PROCEDUREphacoemulsification 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)

PROCEDUREphacoemulsification 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

PROCEDUREphacoemulsification 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

PROCEDUREphacoemulsification 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)

PROCEDUREphacoemulsification 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

PROCEDUREphacoemulsification 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


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT05822089


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