Visual Performance of Patients Implanted With a Multifocal IOL

NCT06111222 | Active Not Recruiting

• 1 other identifier: GPAS-SUR-021-01
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 3

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

Keywords

cataract; multifocal IOL

Outcome Measures

Primary Outcomes (1)

• Mean monocular best-corrected distance visual acuity (CDVA)

  The objective is to evaluate Corrected Distance Visual Acuity (CDVA)

  Three (3) Months

Secondary Outcomes (1)

• Refractive Predictability / Manifest Refraction and Prediction Error

  Twelve (12) Months

Other Outcomes (11)

• Uncorrected Visual Acuities

  Twelve (12) Months

• Corrected Distance Visual Acuities

  Twelve (12) Months

• Corrected Intermediate and Near Visual Acuities

  Twelve (12) Months

Study Arms (1)

Bilateral implantation of investigational device

OTHER

Bilateral implantation of investigational device

Device: AT ELANA

Interventions

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.

Bilateral implantation of investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (3)

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

PVK Precise Vision GmbH

Rheine, 48429, Germany

Location

Ofatlivist Alicante

Alicante, 03001, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 1, 2023
• Study Start: October 31, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); ES (1)