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Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery

Sponsor
Johannes Kepler University of Linz (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06069752
Collaborator
Carl Zeiss (Other)
50
Enrollment
1
Location
35.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.

    In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

    Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.

    Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery
    Actual Study Start Date :
    Mar 8, 2022
    Anticipated Primary Completion Date :
    Feb 28, 2025
    Anticipated Study Completion Date :
    Feb 28, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Tilt and decentration of intraocular lens measured in degrees [1 month post surgery compared with 12 months post surgery]

      Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Adult subject with a minimum age of 22 years

    • Planned natural lens replacement with posterior chamber IOL implantation

    • Clear intraocular media other than cataract

    • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit

    • Ability to consent to the participation in study

    • Signed informed consent

    Exclusion Criteria:

    • Corneal pathology/ectasia

    • Prior ophthalmic surgery

    • Zonular-defects, unstable bag

    • Macular pathologies

    • Expected Visual acuity of less than 0.63 (decimal)

    • Glaucoma

    • Use of systemic or ocular medication that might affect vision

    • Patient is pregnant, plans to become pregnant, is lactating

    • Concurrent participation in any other clinical trial with an investigation product

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kepler University Hospital Linz Upper Austria Austria 4021

    Sponsors and Collaborators

    • Johannes Kepler University of Linz
    • Carl Zeiss

    Investigators

    • Principal Investigator: Matthias Bolz, MD, JKU Linz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthias Bolz, Univ.-Prof. Dr., Johannes Kepler University of Linz
    ClinicalTrials.gov Identifier:
    NCT06069752
    Other Study ID Numbers:
    • KUK-Ophthalmology-003
    First Posted:
    Oct 6, 2023
    Last Update Posted:
    Oct 6, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Eye Diseases

    Study Results

    No Results Posted as of Oct 6, 2023