CClinicalTrials.gg
Sign In
TerminatedNCT04796662CLUSUpdated Feb 24, 2023

CT Lucia 601 IOL Implantation in the Sulcus

An observational study in Cataract; Complicata, Posterior Capsule Tear and Lens Dislocation, sponsored by Universitaire Ziekenhuizen KU Leuven. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-24.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Why this study was terminated
Poor recruitment
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
62
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Cataract; Complicata
  • Posterior Capsule Tear
  • Lens Dislocation

Browse trials for

Keywords

  • CT Lucia 601 lens
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 62 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who had an implantation of the CT Lucia 601 lens

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
62 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. safety of the CT Lucia 601 IOL in the sulcus

    determine whether the CT Lucia 601 IOL can be used safely in the sulcus

    Time frame: 2019-2020

07

Study locations

1 site
  • UZ Leuven
    Leuven, Vlaams Brabant 3000, Belgium
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 22, 2021

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04796662
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Mar 15, 2021
Start date
Mar 8, 2021
Primary completion
Feb 20, 2023
Completion
Feb 20, 2023
Last update
Feb 24, 2023

Study contacts

Peter Stalmans, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cataract→

Other studies from this sponsor

Universitaire Ziekenhuizen KU Leuven

Start the discussion