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:

* Visual acuity
* Intra-ocular pressure
* Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-OCT)
* Any adverse ophthalmic events

Primary outcomes

• 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

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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 Protocol and Statistical Analysis Plan (PDF, 2021-08-22)

• Peter Stalmans, PhD, Principal investigator, UZ Leuven