NCT04796662

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

March 10, 2021

Last Update Submit

February 21, 2023

Conditions

Cataract; ComplicataPosterior Capsule TearLens Dislocation

Keywords

CT Lucia 601 lens

Outcome Measures

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

    2019-2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had an implantation of the CT Lucia 601 lens

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

CataractLens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Peter Stalmans, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

March 8, 2021

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

BE(1)