VISUAL: Visual Performance of Patients Implanted With a Multifocal IOL

Carl Zeiss Meditec AG (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HECATE

Study Design

Study Type:
Anticipated Enrollment :
87 participants
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOLPatients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL
None (Open Label)
Primary Purpose:
Official Title:
Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens
Actual Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Bilateral implantation of investigational device

Bilateral implantation of investigational device

Device: HECATE
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.

Outcome Measures

Primary Outcome Measures

  1. Mean monocular best-corrected distance visual acuity (CDVA) [Three (3) Months]

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

Secondary Outcome Measures

  1. Refractive Predictability / Manifest Refraction and Prediction Error [Twelve (12) Months]

    Descriptive analysis of the manifest refraction parameters sphere, cylinder, and spherical equivalent (MRSE) will be reported to determine refractive predictability

Other Outcome Measures

  1. Uncorrected Visual Acuities [Twelve (12) Months]

    Binocular uncorrected distance, intermediate and near visual acuity (UDVA, UIVA, UNVA)

  2. Corrected Distance Visual Acuities [Twelve (12) Months]

    Best-corrected monocular and binocular distance visual acuity (CDVA)

  3. Corrected Intermediate and Near Visual Acuities [Twelve (12) Months]

    Binocular Distance-corrected intermediate and near visual acuity

  4. Refractive predictability [Twelve (12) Months]

  5. Patient Reported Outcome Measures (PROMs) [Three (3) Months]

  6. Postoperative use of spectacles [Twelve (12) Months]

  7. Defocus Curves [Twelve (12) Months]

    Monocular and Binocular

  8. Binocular Contrast Sensitivity [Twelve (12) Months]

    Photopic and Mesopic

  9. Posterior Capsule Opacification (PCO) [Twelve (12) Months]

  10. Nd:YAG rate [Twelve (12) Months]

    Incidence of Neodymium:yttrium-aluminum-garnet (Nd:YAG) laser capsulotomy as treatment for PCO

  11. Optimization of CZM IOL calculation tools [Twelve (12) Months]

    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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Dr. Pedro Tañá Rivero Alicante Spain 03001

Sponsors and Collaborators

  • Carl Zeiss Meditec AG


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Carl Zeiss Meditec AG Identifier:
Other Study ID Numbers:
  • GPAS-SUR-021-01
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 3, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Carl Zeiss Meditec AG
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2023