Study Results
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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TERMINATED
62 participants
OBSERVATIONAL
2021-03-08
2023-02-20
Brief Summary
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Detailed Description
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* 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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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S64878
Identifier Type: -
Identifier Source: org_study_id
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