Visual Performance of Patients Implanted with a Multifocal IOL

Last updated: February 24, 2025
Sponsor: Carl Zeiss Meditec AG
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

HECATE

Clinical Study ID

NCT06111222
GPAS-SUR-021-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older;

  • Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataractextraction 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 IOLDiopter 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 withexamination procedures;

  • Written informed consent for participation in the study and data protection.

Exclusion

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 thatwould, 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/scotopicconditions);

  • Capsular or zonular abnormalities that may affect postoperative centration or tiltof 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 Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: HECATE
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • PVK Precise Vision GmbH

    Rheine, 48429
    Germany

    Site Not Available

  • Dr. Pedro Tañá Rivero

    Alicante, 03001
    Spain

    Site Not Available

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