CataractIC-CATARACTNCT02837562
Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff
An observational study of Cataract, run by University of Texas Southwestern Medical Center.
Trial summary
The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Slit lamp eye examination
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 1 Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants of the Society of Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, 2016
Who may be able to join
- Willing to undergo eye examination
- Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions
Who cannot join
- Known pre-existing severe eye disease, such as glaucoma
- Prior lens surgery
- Known hypersensitivity to the mydriatic agents
- Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator
About this study
Official title: Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study
The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.
The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.
Read the detailed description
This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.
- Conditions
- Cataract
- Being tested
- Slit lamp eye examination
- Keywords
- Radiation exposure, Cardiac catheterization
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit lamp eye examinationOther
All participants in the trial will undergo a slit lamp eye examination
| Study group | Role | What they receive |
|---|---|---|
| Interventional Cardiology/Cath Lab Staff | This is considered to be the "case" or group under study. These are Interventional Cardiology/ Cardiac Cath lab staff that are exposed to radiation as a result of their role as Cardiac Cath lab staff.
Intervention: Slit lamp eye examination Receives: Other: Slit lamp eye examination | |
| Non-Interventional Cardiology/ Controls | This is considered to be the "control" or comparison group. These are non-interventional cardiology/ non-cardiac cath lab staff that are not exposed to radiation as they do no operate/ work in the Cardiac Cath Lab.
Intervention: Slit lamp eye examination Receives: Other: Slit lamp eye examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation associated lens opacities
Measured by slit-lamp eye examination
Measured: At study completion, approximately 30 minutes after administration of mydriatic eye drops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: 0
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dallas VA Research Corporation
- Responsible party
- Sponsor
- Investigators
- Emmanouil S Brilakis, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837562
- Sponsor's protocol ID
- STU-042016-016
- Acronym
- IC-CATARACT
- Status last verified
- Jan 2019
- First submitted
- 24 Jun 2016
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study
- ClinicalTrials.gov ID
- NCT02837562
- Acronym / sponsor ID
- IC-CATARACT / STU-042016-016
- Conditions
- Cataract
- Keywords
- Radiation exposure, Cardiac catheterization
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Dallas VA Research Corporation
- Study start
- May 2016
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.
The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.
Detailed description
This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Cardiology/Cath Lab Staff | – | Other: Slit lamp eye examinationThis is considered to be the "case" or group under study. These are Interventional Cardiology/ Cardiac Cath lab staff that are exposed to radiation as a result of their role as Cardiac Cath lab staff. Intervention: Slit lamp eye examination |
| Non-Interventional Cardiology/ Controls | – | Other: Slit lamp eye examinationThis is considered to be the "control" or comparison group. These are non-interventional cardiology/ non-cardiac cath lab staff that are not exposed to radiation as they do no operate/ work in the Cardiac Cath Lab. Intervention: Slit lamp eye examination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants of the Society of Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, 2016
Key inclusion criteria (2 listed)
- Willing to undergo eye examination
- Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions
Key exclusion criteria (4 listed)
- Known pre-existing severe eye disease, such as glaucoma
- Prior lens surgery
- Known hypersensitivity to the mydriatic agents
- Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slit lamp eye examinationAll participants in the trial will undergo a slit lamp eye examination | Other | Interventional Cardiology/Cath Lab Staff, Non-Interventional Cardiology/ Controls |
Primary outcome
Radiation associated lens opacities
Time frame: At study completion, approximately 30 minutes after administration of mydriatic eye drops
Measured by slit-lamp eye examination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Emmanouil S Brilakis, MD, PhD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by University of Texas Southwestern Medical Center.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Radiation associated lens opacities (time frame: At study completion, approximately 30 minutes after administration of mydriatic eye drops). 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 18 Jan 2019.