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Poor recruitment
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To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus
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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Patients with an implantation of a CT Lucia 601 lens for different reasons:
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:
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Patients who had an implantation of the CT Lucia 601 lens
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2023 | |
| Reset | Jan 4, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2021 | Jun 21, 2022 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2023 | Jan 4, 2024 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D007906 | Lens Subluxation |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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