Visual Performance of Patients Implanted With a Multifocal IOL

NCT ID: NCT06111222

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-10-31

Brief 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

Cataract; Refractive Lens Exchange

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bilateral implantation of investigational device

Bilateral implantation of investigational device

Group Type: OTHER

AT ELANA

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older;
• Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D
• No visual acuity limiting pathologies other than cataract;
• Corneal Astigmatism of <1.0 D;
• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;
• Written informed consent for participation in the study and data protection.

Exclusion Criteria

• Corneal Astigmatism of ≥1.0 D;
• Difficulty for cooperation (distance from their home, general health conditions);
• History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);
• Visual field loss which has an impact on visual acuity;
• Use of systemic or ocular medication that might affect vision;
• Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
• Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);
• Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);
• Cataract grades of 4, 5 or 6 on the LOCSIII scale ;
• Surgeries with incision size of ≥2.75mm ;
• Immediate Sequential Bilateral Cataract Surgery ;
• Concurrent participation in another device investigation;
• Usage of contact lenses during participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Heidelberg

Heidelberg, , Germany

PVK Precise Vision GmbH

Rheine, , Germany

Ofatlivist Alicante

Alicante, , Spain

Countries

Germany; Spain

Other Identifiers

GPAS-SUR-021-01

Identifier Type: -

Identifier Source: org_study_id