The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
The device is CE-approved. The device is a posterior chamber multifocal intraocular lens (IOL) indicated for aphakia after surgical extraction of the cataractous natural lens. The device is also indicated for non-cataractous, presbyopic patients (PRELEX) who seek greater independence from glasses for intermediate and/or near distances. It is an aspheric (aberration-neutral) IOL made of hydrophobic acrylic material, coated with heparin with modified C-loop haptics.
Universitätsklinikum Heidelberg
Heidelberg, Germany
PVK Precise Vision GmbH
Rheine, Germany
Ofatlivist Alicante
Alicante, Spain
Mean monocular best-corrected distance visual acuity (CDVA)
The objective is to evaluate Corrected Distance Visual Acuity (CDVA)
Time frame: Three (3) Months
Refractive Predictability / Manifest Refraction and Prediction Error
Descriptive analysis of the manifest refraction parameters sphere, cylinder, and spherical equivalent (MRSE) will be reported to determine refractive predictability
Time frame: Twelve (12) Months
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