Status:
NOT_YET_RECRUITING
Vivinex Impress XY1-EM vs RayOne EMV
Lead Sponsor:
Medical University of Bialystok
Conditions:
Cataract
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief 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
Detailed Description
Cataracts are one of the leading causes of visual impairment and blindness worldwide. Modern cataract surgery by phacoemulsification with intraocular lens implantation is the gold standard of treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06891092
Start Date
June 1 2025
End Date
June 1 2028
Last Update
March 24 2025
Active Locations (1)
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1
Medical University of Bialystok
Bialystok, Polska, Poland, 15-866