RecruitingNot ApplicableNCT06891092

Vivinex Impress XY1-EM vs RayOne EMV

Comparison of Quality of Vision After Implantation of Monofocal Depth-enhanced Intraocular Lenses in Patients Undergoing Bilateral Cataract Surgery


Sponsor

Medical University of Bialystok

Enrollment

100 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Comparison of the outcomes of bilateral implantation of extended depth of vision (EDOF) intraocular lenses (IOLs): the Rayone EMV and the Vivinex Impress XY1-EM in patients with cataract


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria6

  • age-related bilateral cataract
  • age 21 or older
  • visual acuity > 0.05
  • axial length: 22.0 - 26.0 mm
  • normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • written informed consent prior to surgery

Exclusion Criteria7

  • active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)
  • corneal decompensation or corneal endothelial cell insufficiency
  • previous ocular surgery or trauma
  • persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
  • corneal astigmatism > 1 dpt.
  • retinopathies

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Interventions

DEVICERayOne EMV

non-diffractive monofocal IOL

DEVICEVivinex Impress

non-diffractive monofocal IOL


Locations(1)

Medical University of Bialystok

Bialystok, Polska, Poland

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NCT06891092


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