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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04417244
Other study ID # 2020 ADV-OPH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 21, 2019
Est. completion date October 2022

Study information

Verified date May 2020
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 0473754963
Email pormo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ophtalmologist or orthoptist (interns, graduates and retirees)

- French

Exclusion Criteria:

- Foreign practitionner

Study Design


Locations

Country Name City State
France University hospital, Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary epidemiology characteristics history of adenovirus keratoconjunctivitis; history of sequels Day 1
Primary general characteristics - Sex general characteristics - Sex Day 1
Primary general characteristics - Age range general characteristics - Age range Day 1
Primary general characteristics - Profession general characteristics - Profession Day 1
Secondary administrative procedure declaration occupational disease declaration, sick leave, cessation of surgery and duration Day 1
Secondary infection characteristics bilaterality, season, anteriority, sequels, current therapy, professional discomfort Day 1
Secondary risk factor refractive surgery history, wearing of eyeglasses or contact lenses, smoking, corticosteroid therapy Day 1
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05123014 - Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease N/A
Not yet recruiting NCT04041856 - Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis Phase 1/Phase 2
Completed NCT04376970 - Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis Phase 4