CT Lucia 601 IOL Implantation in the Sulcus

Posterior Capsule Tear Clinical Trial

— CLUS  

Official title:

CT Lucia 601 IOL Implantation in the Sulcus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04796662
• Other study ID #: S64878
• Status: Terminated
• Start date: March 8, 2021
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract; Complicata
• Lens Dislocation
• Lens Subluxation
• Posterior Capsule Tear

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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