CT Lucia 601 IOL Implantation in the Sulcus (CLUS)

February 21, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who had an implantation of the CT Lucia 601 lens

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of the CT Lucia 601 IOL in the sulcus
Time Frame: 2019-2020
determine whether the CT Lucia 601 IOL can be used safely in the sulcus
2019-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Actual)

February 20, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64878

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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