Trials / Active Not Recruiting
Active Not RecruitingNCT06111222
Visual Performance of Patients Implanted With a Multifocal IOL
Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- Sponsor
- Carl Zeiss Meditec AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AT ELANA | 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. |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
- First posted
- 2023-11-01
- Last updated
- 2025-07-18
Locations
3 sites across 2 countries: Germany, Spain
Source: ClinicalTrials.gov record NCT06111222. Inclusion in this directory is not an endorsement.