Adenoviral KeratoconjunctivitisADV-OPHNCT04417244
Adenovirus Keratoconjunctivitis and Ophtalmology
An observational study of Adenoviral Keratoconjunctivitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenoviral Keratoconjunctivitis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2019to Oct 2022
- 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: French Ophtalmologist or orthoptist
Who may be able to join
- Ophtalmologist or orthoptist (interns, graduates and retirees)
- French
Who cannot join
- Foreign practitionner
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital, Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Frédéric Dutheil, MD, PhD
About this study
Official title: Complications of Adenovirus Keratoconjunctivitis in Ophthalmologists and Orthoptists: Epidemiology and Risk Factor, a Retrospective Questionnaire Analysis
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.
The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist.
Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave),infections characteristics; and risk factors.
Read the detailed description
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.
The investigation tream create a nationwide anonymous retrospective questionnaire using the secure internet application REDCap® to build and manage the questionnaire addressed to ophtalmologists (interns, graduates and retirees) and orthoptists.
Investigator collect several characteristics such as general characteristics (sex, age range, profession), administrative procedure declaration (occupational disease declaration, sick leave, cessation of surgery); infection characteristics (bilaterality, season, anteriority, sequels, current therapy, professional discomfort), risk factor (refractive surgery history, wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy).
The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist. Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave), infections characteristics; and risk factors such as a refractive surgery history, the wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy.
- Conditions
- Adenoviral Keratoconjunctivitis
- Keywords
- Adenovirus, Epidemic Keratoconjunctivitis, Subepithelial infiltrates, Occupational diseases, Ophtalmologists, Orthoptists, Epidemiology
- Medical subject headings
- Adenoviridae Infections, Occupational Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
epidemiology characteristics
history of adenovirus keratoconjunctivitis; history of sequels
Measured: Day 1
general characteristics - Sex
general characteristics - Sex
Measured: Day 1
general characteristics - Age range
general characteristics - Age range
Measured: Day 1
general characteristics - Profession
general characteristics - Profession
Measured: Day 1
Secondary outcomes (3)
administrative procedure declaration
occupational disease declaration, sick leave, cessation of surgery and duration
Measured: Day 1
infection characteristics
bilaterality, season, anteriority, sequels, current therapy, professional discomfort
Measured: Day 1
risk factor
refractive surgery history, wearing of eyeglasses or contact lenses, smoking, corticosteroid therapy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Oct 2019
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417244
- Sponsor's protocol ID
- 2020 ADV-OPH
- Acronym
- ADV-OPH
- Status last verified
- May 2020
- First submitted
- 2 Jun 2020
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications of Adenovirus Keratoconjunctivitis in Ophthalmologists and Orthoptists: Epidemiology and Risk Factor, a Retrospective Questionnaire Analysis
- ClinicalTrials.gov ID
- NCT04417244
- Acronym / sponsor ID
- ADV-OPH / 2020 ADV-OPH
- Conditions
- Adenoviral Keratoconjunctivitis
- Keywords
- Adenovirus, Epidemic Keratoconjunctivitis, Subepithelial infiltrates, Occupational diseases, Ophtalmologists, Orthoptists, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 4 Jun 2020 (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.
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.
The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist.
Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave),infections characteristics; and risk factors.
Detailed description
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.
The investigation tream create a nationwide anonymous retrospective questionnaire using the secure internet application REDCap® to build and manage the questionnaire addressed to ophtalmologists (interns, graduates and retirees) and orthoptists.
Investigator collect several characteristics such as general characteristics (sex, age range, profession), administrative procedure declaration (occupational disease declaration, sick leave, cessation of surgery); infection characteristics (bilaterality, season, anteriority, sequels, current therapy, professional discomfort), risk factor (refractive surgery history, wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy).
The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist. Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave), infections characteristics; and risk factors such as a refractive surgery history, the wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- French Ophtalmologist or orthoptist
Key inclusion criteria (2 listed)
- Ophtalmologist or orthoptist (interns, graduates and retirees)
- French
Key exclusion criteria (1 listed)
- Foreign practitionner
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
epidemiology characteristics
Time frame: Day 1
history of adenovirus keratoconjunctivitis; history of sequels
general characteristics - Sex
Time frame: Day 1
general characteristics - Sex
general characteristics - Age range
Time frame: Day 1
general characteristics - Age range
general characteristics - Profession
Time frame: Day 1
general characteristics - Profession
3 secondary outcomes
administrative procedure declaration
Time frame: Day 1
infection characteristics
Time frame: Day 1
risk factor
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Related trials for Adenoviral Keratoconjunctivitis
Active, not recruiting
Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
Adenoviral Keratoconjunctivitis
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.
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 Adenoviral Keratoconjunctivitis, run by University Hospital, Clermont-Ferrand 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 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473754963, pormo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidemiology characteristics (time frame: Day 1). The study lists 4 primary outcomes in all. 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 4 Jun 2020.