NCT04796662

Terminated

CT Lucia 601 IOL Implantation in the Sulcus

Universitaire Ziekenhuizen KU Leuven Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

S64878

Study Type

observational

Actual enrollment (reported)

62

Locations

1 country

Sites

1

Timeline

Study Start

March 8, 2021

Actual (reported)

Primary Completion

February 20, 2023

Actual (reported)

Study Completion

February 20, 2023

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 62 participants
Study completion date: February 20, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 8, 2021
Actual (reported)
First Submitted
March 10, 2021
Actual (reported)
First Posted
March 15, 2021
Actual (reported)
Primary Completion
February 20, 2023
Actual (reported)
Study Completion
February 20, 2023
Actual (reported)

Last Updated: February 24, 2023
Status Verified: February 2023
Last Update Submitted: February 21, 2023

Conditions

Cataract; Complicata Lens Dislocation Posterior Capsule Tear

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:

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

MeSH Terms

Conditions

CataractLens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

Peter Stalmans, PhD
UZ Leuven
PRINCIPAL INVESTIGATOR

Enrollment

62 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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.

February 20, 2023

Actual (reported)

Study Completion

February 20, 2023

Actual (reported)

Last Updated

February 24, 2023

Record last verified: 2023-02

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04796662
Data provider: ClinicalTrials.gov
Source updated: 2023-02-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:57 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2021-08-22

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations