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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04796662
Other study ID # S64878
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 8, 2021
Est. completion date February 20, 2023

Study information

Verified date February 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Terminated
Enrollment 62
Est. completion date February 20, 2023
Est. primary completion date February 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary safety of the CT Lucia 601 IOL in the sulcus determine whether the CT Lucia 601 IOL can be used safely in the sulcus 2019-2020
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