Vivinex Impress XY1-EM vs RayOne EMV

Launched by MEDICAL UNIVERSITY OF BIALYSTOK · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two types of intraocular lenses (IOLs) called Vivinex Impress XY1-EM and RayOne EMV, which are used in cataract surgery. The goal is to see how well these lenses work for improving vision in patients who have cataracts in both eyes. The trial is not yet recruiting participants, but it aims to include adults aged 21 and older who have age-related cataracts and can see well enough (with a visual acuity greater than 0.05) to be considered for surgery.

To participate in this trial, individuals must meet certain criteria, such as having cataracts in both eyes and a specific range of eye measurements. However, people with certain eye diseases, a history of eye surgery, or those who are pregnant or nursing cannot take part. Anyone who enrolls in the study will have the opportunity to receive one of the two lens types and will be closely monitored to see how well they help with vision after surgery. It's an important step in understanding which lens might provide better outcomes for cataract patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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