CT Lucia 601 IOL Implantation in the Sulcus

NCT ID: NCT04796662

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2023-02-20

Brief Summary

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

Detailed Description

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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

Conditions

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Cataract; Complicata Posterior Capsule Tear Lens Dislocation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Stalmans, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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S64878

Identifier Type: -

Identifier Source: org_study_id

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