CataractsNCT01061463
Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study
An observational study of Cataracts and Lens Opacities, run by Sophie JACOB at 1 site in France.
Trial summary
The purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataracts, Lens Opacities
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Mar 2011
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Interventional and non-interventional cardiologists from public and private French hospitals/facilities, both groups of cardiologists being matched for age and gender.
Who may be able to join
- aged at least 40 yrs old
- for interventional cardiologists: cumulated number of procedures > 2000
Who cannot join
- previous history of medical radiation exposure for radiotherapy or brain scans
- for non-interventional cardiologists: occupational history of interventional cardiologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists
The purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays.
Read the detailed description
This cross-sectional study includes cardiologists aged > 40 years: a group of interventional cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed workers (including cardiologists). Individual information, including risk factors of cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. For the exposed group, a specific section of the questionnaire is focused on the occupational history, the description of the procedures (type, frequency, radiation protection tool) and will be used for the classification into "comparable exposure level" groups according to estimates of cumulative dose. For all participants, eye examinations are performed to specifically detect cataracts even in the early stages (lens opacities, LOCS III according to the international standard classification).
- Conditions
- Cataracts, Lens Opacities
- Keywords
- Radiation cataracts, Lens opacities, X-rays, Interventional Cardiologists, Electrophysiologists
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | French coronary interventional cardiologists and cardiologists specializing in cardiac arrhythmias treatments (electrophysiologists), occupationally exposed to X-Rays | |
| Unexposed group | French non-interventional cardiologists and non medical workers, not occupationally exposed to X-Rays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens opacities
Measured: up to 1.5 year
Secondary outcomes (2)
Visual acuity
Measured: up to 1.5 year
Major eye disorders (glaucoma, etc…)
Measured: up to 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophie JACOB
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Sophie JACOB, French Nuclear Safety and Radiation Protection Authority (ASNR)
- Investigators
- Sophie JACOB, PhD., Principal investigator, French Nuclear Safety and Radiation Protection Authority (ASNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061463
- Sponsor's protocol ID
- IRSN-09079
- Status last verified
- Apr 2015
- First submitted
- 2 Feb 2010
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacob S, Michel M, Spaulding C, Boveda S, Bar O, Brezin AP, Streho M, Maccia C, Scanff P, Laurier D, Bernier MO. Occupational cataracts and lens opacities in interventional cardiology (O'CLOC study): are X-Rays involved? Radiation-induced cataracts and lens opacities. BMC Public Health. 2010 Sep 8;10:537. doi: 10.1186/1471-2458-10-537.
PubMed 20825640
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists
- ClinicalTrials.gov ID
- NCT01061463
- Acronym / sponsor ID
- IRSN-09079
- Conditions
- Cataracts, Lens Opacities
- Keywords
- Radiation cataracts, Lens opacities, X-rays, Interventional Cardiologists, Electrophysiologists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sophie JACOBOther government
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Feb 2010 (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 purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays.
Detailed description
This cross-sectional study includes cardiologists aged > 40 years: a group of interventional cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed workers (including cardiologists). Individual information, including risk factors of cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. For the exposed group, a specific section of the questionnaire is focused on the occupational history, the description of the procedures (type, frequency, radiation protection tool) and will be used for the classification into "comparable exposure level" groups according to estimates of cumulative dose. For all participants, eye examinations are performed to specifically detect cataracts even in the early stages (lens opacities, LOCS III according to the international standard classification).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | –French coronary interventional cardiologists and cardiologists specializing in cardiac arrhythmias treatments (electrophysiologists), occupationally exposed to X-Rays |
| Unexposed group | – | –French non-interventional cardiologists and non medical workers, not occupationally exposed to X-Rays |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Interventional and non-interventional cardiologists from public and private French hospitals/facilities, both groups of cardiologists being matched for age and gender.
Key inclusion criteria (2 listed)
- aged at least 40 yrs old
- for interventional cardiologists: cumulated number of procedures > 2000
Key exclusion criteria (2 listed)
- previous history of medical radiation exposure for radiotherapy or brain scans
- for non-interventional cardiologists: occupational history of interventional cardiologist
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
Lens opacities
Time frame: up to 1.5 year
2 secondary outcomes
Visual acuity
Time frame: up to 1.5 year
Major eye disorders (glaucoma, etc…)
Time frame: up to 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Derived from this study: PubMed 20825640Jacob S, Michel M, Spaulding C, Boveda S, Bar O, Brezin AP, Streho M, Maccia C, Scanff P, Laurier D, Bernier MO. Occupational cataracts and lens opacities in interventional cardiology (O'CLOC study): are X-Rays involved? Radiation-induced cataracts and lens opacities. BMC Public Health. 2010 Sep 8;10:537. doi: 10.1186/1471-2458-10-537.
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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.
Sophie JACOB, PhD. principal investigator
French Nuclear Safety and Radiation Protection Authority (ASNR)
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 Cataracts and Lens Opacities, run by Sophie JACOB at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 6 Apr 2015. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lens opacities (time frame: up to 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061463, which also lists 1 linked publication.
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 6 Apr 2015.