Cataract Presbyopia
Conditions
Interventions
Subject will receive the PRECIZION Presbyopia multifocal IOL in both eyes
(bilateral implantation). Surgical procedure and medication regime are standard
for cataract surgery.
intraocular lens
ophtec
Sponsors
OPHTEC BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Patient must be 45 years of age or older * Presbyopic * Cataract patient or Clear Lens Extraction (CLE) candidate * Patient wishes to be spectacle independent for near and far vision * Patient lifestyle and outlook fit with multifocal IOL implantation * Qualifies for bilateral implantation * Patients must have a calculated IOL power within the available diopter range * Expected best corrected visual acuity of 0.5 or better after IOL implantation * No secondary surgical procedure planned during the course of the study * Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study * Patients must provide written informed consent * The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be
Exclusion criteria
Exclusion criteria: * Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders) * Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject * Endothelial cell count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the PRECIZION Presbyopic IOL, by documenting: * Improvement in uncorrected near visual acuity (UNVA) * Improvement in uncorrected intermediate visual acuity (UIVA) * Improvement in uncorrected distance visual acuity (UDVA) * Improvement in combined distance and near uncorrected visual acuities * Improvement in spectacle dependency * Stability of manifest refraction spherical equivalent (MRSE) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following objectives are considered secondary: - To evaluate contrast sensitivity - To evaluate the defocus - To evaluate rates of adverse events/complications - To evaluate patient satisfaction and quality of vision | — |
Countries
Belgium, Germany, Netherlands, Spain, Turkey
Outcome results
None listed