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CLUS: CT Lucia 601 IOL Implantation in the Sulcus

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04796662
Collaborator
(none)
100
Enrollment
1
Location
21
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of the study is to collect data that are parameters of post-IOL implantation safety:

    • Questionnaire on subjective quality of vision

    • Centration and anteroposterior position of the IOL (using biometry)

    • Presence and quantification of any inflammation or pigment present in the anterior chamber (flare meter)

    • Refractive outcome, with calculation of customized A-constant of the CT Lucia 601 IOL in-the-sulcus and quantification of higher-order aberrations (HOA)

    • General safety-parameters:

    • Visual acuity

    • Intra-ocular pressure

    • Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-OCT)

    • Any adverse ophthalmic events

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    CT Lucia 601 IOL Implantation in the Sulcus
    Actual Study Start Date :
    Mar 8, 2021
    Anticipated Primary Completion Date :
    Dec 8, 2022
    Anticipated Study Completion Date :
    Dec 8, 2022

    Outcome Measures

    Primary Outcome Measures

    1. safety of the CT Lucia 601 IOL in the sulcus [2019-2020]

      determine whether the CT Lucia 601 IOL can be used safely in the sulcus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with an implantation of a CT Lucia 601 lens for different reasons:

    • During vitrectomy to treat a complicated cataract surgery and had the implantation of a CT Lucia 601 IOL in the sulcus or patients

    • During phaco surgery with a posterior capsule tear that necessitated the implantation of the implant lens in the sulcus

    • Explantation of an in-the-bag lens and implantation of a CT Lucia 601 as replacement lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens).

    • Age : > 18 years

    • Signed informed consent

    • Preoperative myopia less than 10 diopters

    • Implantation of the CT Lucia IOL at least six months earlier

    Exclusion Criteria:

    • History of uveitis

    • Ocular pathology or history that could influence the biometry of the effective lens position, such as ocular trauma with zonulolysis, congenital iris- or lens defects etc.

    • Any eye condition influencing the lens position (to be specified) according to the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Peter Stalmans, PhD, UZ Leuven

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04796662
    Other Study ID Numbers:
    • S64878
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universitaire Ziekenhuizen Leuven
    CT Lucia 601 lens
    Additional relevant MeSH terms:
    Cataract
    Lens Subluxation

    Study Results

    No Results Posted as of Aug 19, 2022