Vivinex Impress XY1-EM versus RayOne EMV intraocular lenses for cataract
Official title: Comparison of Quality of Vision After Implantation of Monofocal Depth-enhanced Intraocular Lenses in Patients Undergoing Bilateral Cataract Surgery
Run by Medical University of Bialystok · NCT06891092 · Data updated 2026-11-12
This test compares two extended depth-of-vision intraocular lenses—the Vivinex Impress XY1-EM and the RayOne EMV—to see which gives better distance and intermediate vision after cataract surgery in adults with age-related bilateral cataracts.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Medical University of Bialystok Academic / other |
| Locations | 1 site (Bialystok, Polska) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06891092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 or older with age-related bilateral cataracts, axial length 22.0–26.0 mm, visual acuity >0.05, corneal astigmatism ≤1 D, no significant ocular comorbidities, and able to give informed consent.
✕Probably not a fit
Patients with active ocular disease (for example severe uveitis, proliferative diabetic retinopathy, uncontrolled glaucoma), prior ocular surgery or trauma, corneal endothelial insufficiency, significant retinopathies, corneal astigmatism >1 D, or who are pregnant or nursing are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with age-related bilateral cataracts who meet axial length and vision criteria will receive bilateral implantation with one of two extended depth-of-vision (EDOF) intraocular lenses, and outcomes will be compared. The trial tracks postoperative uncorrected and corrected visual acuity at distance and intermediate ranges, as well as safety and visual side effects. Key eligibility rules exclude active ocular disease, prior ocular surgery, significant corneal astigmatism, and retinal pathology. All procedures and follow-up visits are conducted at the Medical University of Bialystok in Poland.
Why it matters
Potential benefit: If successful, one lens could offer better uncorrected distance and intermediate vision and reduce patients' dependence on glasses after cataract surgery.
How similar studies have gone: Previous studies of EDOF intraocular lens designs have generally shown improved intermediate vision with relatively low rates of dysphotopsias compared with multifocal lenses.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Medical University of Bialystok
Bialystok, Polska, Poland Recruiting
Study contacts
- Study coordinator: Joanna Konopinska, Associate proffesor
- Email: joannakonopinska@o2.pl
- Phone: +48600471666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.