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
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
January 20, 2026
January 1, 2026
1.4 years
March 17, 2025
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual acuity at intermediate distance
The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs. The higer the number the better outcome.
3 months
Secondary Outcomes (3)
Visual acuity at far distance
3 months
Visual acuity at near distance
3 months
Change from baseline in the quality of life
3 months
Study Arms (2)
Rayone EMV
EXPERIMENTALPatient will receive the non-diffractive monofocal IOL during cataract surgery
Vivinex Impress XY1-EM
EXPERIMENTALPatient will receive the non-diffractive monofocal IOL during cataract surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Bialystok
Bialystok, Polska, 15-866, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2025
First Posted
March 24, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
De-identified participant data that underlie the results reported in this study will be available upon reasonable request for academic and non-commercial purposes beginning with results publication and ending 5 years thereafter. Proposals should be submitted to main investigator.