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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral implantation of investigational device | Other | Bilateral implantation of investigational device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT ELANA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean monocular best-corrected distance visual acuity (CDVA) | The objective is to evaluate Corrected Distance Visual Acuity (CDVA) | Three (3) Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Twelve (12) Months |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuities | Binocular uncorrected distance, intermediate and near visual acuity (UDVA, UIVA, UNVA) | Twelve (12) Months |
| Corrected Distance Visual Acuities | Best-corrected monocular and binocular distance visual acuity (CDVA) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany | |||
| PVK Precise Vision GmbH |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL
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|
| Twelve (12) Months |
| Corrected Intermediate and Near Visual Acuities | Binocular Distance-corrected intermediate and near visual acuity | Twelve (12) Months |
| Refractive predictability | Twelve (12) Months |
| Patient Reported Outcome Measures (PROMs) | Three (3) Months |
| Postoperative use of spectacles | Twelve (12) Months |
| Defocus Curves | Monocular and Binocular | Twelve (12) Months |
| Binocular Contrast Sensitivity | Photopic and Mesopic | Twelve (12) Months |
| Posterior Capsule Opacification (PCO) | Twelve (12) Months |
| Nd:YAG rate | Incidence of Neodymium:yttrium-aluminum-garnet (Nd:YAG) laser capsulotomy as treatment for PCO | Twelve (12) Months |
| Optimization of CZM IOL calculation tools | Anonymized Biometry raw data will be collected and used to optimize Carl ZEISS Meditec IOL calculation tools, such as the ZEISS IOL Power Calculation Service and algorithms of the optical biometer IOL Master 700, to improve future clinical outcomes. | Twelve (12) Months |
| Rheine |
| 48429 |
| Germany |
| Ofatlivist Alicante | Alicante | 03001 | Spain |