CT Lucia 601 IOL Implantation in the Sulcus

Terminated

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

• Registration Number: NCT04796662
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Study Start: 2021-03-08
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Status Verified: 2023-02
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium