RECRUITINGINTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form prior to surgery
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
RayOne EMV
non-diffractive monofocal IOL
DEVICE
Vivinex Impress
non-diffractive monofocal IOL
Locations (1)
Medical University of Bialystok
Bialystok, Polska, Poland