CT Lucia 601 IOL Implantation in the Sulcus

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04796662

Acronym

CLUS

Enrollment

Registered

2021-03-15

Start date

2021-03-08

Completion date

2023-02-20

Last updated

2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract; Complicata, Lens Dislocation, Posterior Capsule Tear

Keywords

CT Lucia 601 lens

Brief summary

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

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Belgium

Outcome results