CT Lucia 601 IOL Implantation in the Sulcus (CLUS)

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Lens Dislocation; Posterior Capsule Tear; Cataract; Complicata

Study type: Observational

Funder types: Other

Identifiers

NCT04796662

S64878

Details and patient eligibility

About

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

Full 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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design