Skip to main content
OpenTrials
Completed

NCT Number: NCT06111222

Visual Performance of Patients Implanted With a Multifocal IOL

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Heidelberg, Heidelberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Mean monocular best-corrected distance visual acuity (CDVA)

    Time frame: Three (3) Months

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

Secondary outcomes

  1. Refractive Predictability / Manifest Refraction and Prediction Error

    Time frame: Twelve (12) Months

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

Other outcomes

  1. Uncorrected Visual Acuities

    Time frame: Twelve (12) Months

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

  2. Corrected Distance Visual Acuities

    Time frame: Twelve (12) Months

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

  3. Corrected Intermediate and Near Visual Acuities

    Time frame: Twelve (12) Months

    Binocular Distance-corrected intermediate and near visual acuity

  4. Refractive predictability

    Time frame: Twelve (12) Months

  5. Patient Reported Outcome Measures (PROMs)

    Time frame: Three (3) Months

  6. Postoperative use of spectacles

    Time frame: Twelve (12) Months

  7. Defocus Curves

    Time frame: Twelve (12) Months

    Monocular and Binocular

  8. Binocular Contrast Sensitivity

    Time frame: Twelve (12) Months

    Photopic and Mesopic

  9. Posterior Capsule Opacification (PCO)

    Time frame: Twelve (12) Months

  10. Nd:YAG rate

    Time frame: Twelve (12) Months

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

  11. Optimization of CZM IOL calculation tools

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Acronym: VISUAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.