Cataract clouding of the lens
Conditions
Interventions
All patients will recieve a standard cataract surgery on both eyes with the
phacoemulsification technique. One group receives bilateral implantation with
the Acunex® Vario IOL and the other group re
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Minimum 18 years of age - Bilateral cataract - Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ Vivity® IOL - Expected postoperative astigmatism
Exclusion criteria
Exclusion criteria: - Previous corneal surgery and/or reshaping - 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 (eg. glaucoma, cerebral vascular accident (CVA), hemianopsia, etc.) - Extensive diabetic retinopathy - Amblyopia, strabismus, diplopia - Pseudo exfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL - Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic /scotopic conditions) - Cognitive cerebral or concentration disorders (e.g., dementia, Parkinson, stroke, etc.) - Suturing of incision required at time of surgery - Complications during surgery of the first eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the binocular UIVA at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Acunex® Vario IOL versus those bilaterally implanted with the Alcon AcrySof® IQ Vivity® IOL. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean mono- & binocular uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) at 4 mtrs 1 week, and 1 and 3 months postoperatively - Mean binocular distance-corrected intermediate visual acuity ((DCIVA) at 66 cm at 1 and 3 months postoperatively - Mean binocular uncorrected near visual acuity (UNVA) and distance corrected near visual acuity (DCNVA) at 40 cm at 1 and 3 months postoperatively - Binocular defocus curves under photopic conditions at 3 months postoperatively - Mean contrast sensitivity binocular at photopic and mesopic conditions at 3 months postoperatively - Tilt and decentration of the IOL 1 month postoperatively - Complication profile including halos and glare (all visits) according to the Likert scale - Questionnaires on patient satisfaction including spectacle independence (IOLSAT) and occurrence of optical complaints (Catquest-NL and QoV-NL) at 3 months postoperatively | — |
Countries
Netherlands
Outcome results
None listed