Cataract
Conditions
Interventions
All patients will receive a standard cataract surgery on both eyes with the 
phacoemulsification technique. One group receives bilateral implanation with 
the Clareon  
Vivity IOL (EDOF IOL - intervention-group) and the other group 
receives bilateral implanation with the Clareon  
Monofocal IOL (Monofocal IOL 
- controlgroup). total of 48 patients will be randomized into either the 
intervention-group or the control-group at a 1:1 ratio.
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Minimum 18 years of ageBilateral age-related cataractBilateral implantation of either the Alcon Clareon Vivity® IOL or Alcon Clareon monofocal IOL Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and a modification of the corneal incision resulting in a postoperative predicted astigmatism of 0.50D or lessIOL power calculation between +10.0 D and +30.0 DExpected postoperative best-corrected visual acuity of logMAR +0.2 or betterPrevious refractive corneal laser surgery for correction of myopia (LASIK, LASEK and PRK).Availability to undergo second eye surgery within 2 weeks after the first eye surgeryWilling and able to comply with scheduled visits and other study proceduresSigned informed consent
Exclusion criteria
Exclusion criteria: Patients with a pre-laser myopia exceeding 6.0DPreoperative central corneal thickness <400 micronCorneal total higher order aberration >0.4 micron in a 4mm pupil (measured via pre-op Pentacam)Corneal pathology (i.e. Fuchs endothelial dystrophy (FED), irregular astigmatism, herpes simplex virus (HSV) keratitis)Extensive age-related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen) and post-intravitreal injection (IVI)Extensive visual field loss (e.g. glaucoma, cerebral vascular accident, hemianopsia)Extensive diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the mean binocular DCIVA at 66 cm under photopic conditions 3 months after cataract surgery, in a series of patients, who previously underwent myopic laser surgery, bilaterally implanted with the non-diffractive advanced monofocal Clareon Vivity® IOL (intervention-group) versus the Alcon monofocal Clareon IOL (control-group) both targeted for mini-monovision. | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity outcomes at 1 week postoperatively:Monocular uncorrected distance visual acuity (UDVA) at 4m, using the ETDRS or Snellen chartMonocular corrected distance visual acuity (CDVA) at 4m, using the ETDRS or Snellen chartVisual acuity outcomes at 4 weeks postoperatively:Monocular uncorrected distance visual acuity (UDVA) at 4m, using the ETDRS chartMonocular corrected distance visual acuity (CDVA) at 4m, using the ETDRS chartVisual outcomes at 3 months postoperatively:Monocular and binocular uncorrected distance visual acuity (UDVA) at 4 m, using the ETDRS chartMonocular and binocular corrected distance visual acuity (CDVA) at 4 m, using the ETDRS chartMonocular and binocular uncorrected and distance-corrected intermediate visual acuity (UIVA and DCIVA) at 66 cm, using the ETDRS chartMonocular and binocular distance-corrected near visual acuity (UNVA and DCNVA) at 40 cm, using the ETDRS chartBinocular target corrected distance, intermediate, and near visual acuity (TCDVA, TCIVA, and TCNVA)The percentage of eyes in which the postoperative manifest refractive spherical equivalent (MRSE) is within ± 0.25, 0.50, 0.75 and 1.00 D of the target refraction.Uncorrected distance visual acuity distribution subset analysis based on pre-laser surgery refraction.Binocular uncorrected and target corrected defocus curve at 4 m (ranging from +1.50D to -2.50D) at 3 months postoperatively, in photopic conditions.Patient-reported outcomes, using the validated version of the Catquest-SF9 questionnaire, at 3 months postoperatively.Questionnaire on patient spectacle independence (IOLSAT) and occurrence of optical complaints (QoV) at 3 months postoperatively. | — |
Countries
Germany, Netherlands
Contacts
Public ContactJ.C. Wanten
Maastricht Universitair Medisch Centrum +
Outcome results
None listed