RECRUITINGINTERVENTIONAL
Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses
Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses
About This Trial
Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.
Who May Be Eligible (Plain English)
Who May Qualify:
- Bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- Axial length: 22.00-26.00mm
- 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
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Who Should NOT Join This Trial:
- Active ocular disease (e.g. chronic 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
- Amblyopia
- Previous ocular surgery or trauma
- Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
- Astigmatism with the need for a toric IOL
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Bilateral cataract
* Age 21 or older
* Visual acuity \> 0.05
* Axial length: 22.00-26.00mm
* 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
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
* Active ocular disease (e.g. chronic 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
* Amblyopia
* Previous ocular surgery or trauma
* Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
* Astigmatism with the need for a toric IOL
Treatments Being Tested
DEVICE
Evolux
Evolux, enhanced monofocal IOL
DEVICE
Tecnis Eyhance
Tecnis Eyhance, enhanced monofocal IOL
Locations (1)
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna
Vienna, Austria