Cataract; ComplicataCLUSNCT04796662
CT Lucia 601 IOL Implantation in the Sulcus
An observational study of Cataract; Complicata and Posterior Capsule Tear, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract; Complicata, Posterior Capsule Tear, Lens Dislocation
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2021to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had an implantation of the CT Lucia 601 lens
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Keywords
- CT Lucia 601 lens
- Medical subject headings
- Cataract, Lens Subluxation
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of the CT Lucia 601 IOL in the sulcus
determine whether the CT Lucia 601 IOL can be used safely in the sulcus
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start8 Mar 2021
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract; ComplicataStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796662
- Sponsor's protocol ID
- S64878
- Acronym
- CLUS
- Status last verified
- Feb 2023
- First submitted
- 10 Mar 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Lucia 601 IOL Implantation in the Sulcus
- ClinicalTrials.gov ID
- NCT04796662
- Acronym / sponsor ID
- CLUS / S64878
- Keywords
- CT Lucia 601 lens
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had an implantation of the CT Lucia 601 lens
Key inclusion criteria (8 listed)
- Patients with an implantation of a CT Lucia 601 lens for different reasons:
- Age : > 18 years
- Signed informed consent
- Preoperative myopia less than 10 diopters
- Implantation of the CT Lucia IOL at least six months earlier
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
safety of the CT Lucia 601 IOL in the sulcus
Time frame: 2019-2020
determine whether the CT Lucia 601 IOL can be used safely in the sulcus
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stalmans, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract; Complicata and Posterior Capsule Tear, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of the CT Lucia 601 IOL in the sulcus (time frame: 2019-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.