Visual Performance of Patients Implanted With a Multifocal IOL (VISUAL)

Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens

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 Overview

• Status: Active, not recruiting
• Conditions: Cataract; Refractive Lens Exchange
• Intervention / Treatment: Device: AT ELANA

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Rheine, Germany, 48429
    • PVK Precise Vision GmbH
• Spain
  • Alicante, Spain, 03001
    • Ofatlivist Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Bilateral implantation of investigational device

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cataract; multifocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GPAS-SUR-021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No