| Registry | NCT07828821, acronym RETINOMED |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 400 (Estimated) |
| Sponsor | University Hospital, Clermont-Ferrand (Other) |
| Conditions | Diabetic Retinopathy |
| Interventions | Non-mydriatic retinography, Self-administered questionnaire (Device, other) |
| Dates | start 2026-10-01 (estimated), primary completion 2029-06-01 (estimated), completion 2029-06-01 (estimated), first posted 2026-09-18, last updated 2026-09-18 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetic Retinopathy All trials of Non-mydriatic retinography All trials of Self-administered questionnaire
Diabetic retinopathy is a complication of diabetes that can affect vision. Early detection and appropriate management can help prevent or delay vision loss. However, some people with diabetes do not receive the recommended regular eye examinations.
The RETINOMED study is a pilot study designed to evaluate the feasibility of offering diabetic retinopathy screening to workers with diabetes through an Occupational Health service.
Participants will attend a single study visit at the Occupational Health Department of Clermont-Ferrand University Hospital. During this visit, retinal photographs will be taken using a non-mydriatic retinal camera, which does not require pupil dilation. Participants will also complete a questionnaire about their sociodemographic and occupational characteristics, lifestyle, and diabetes.
The study will assess the acceptability of this screening program among eligible workers. It will also estimate the prevalence of diabetic retinopathy among screened workers and explore participant characteristics that may be associated with diabetic retinopathy.
RETINOMED is a monocentric, pilot exploratory study conducted at the Occupational Health Department of Clermont-Ferrand University Hospital, France. The study primarily aims to assess the feasibility of implementing diabetic retinopathy screening in an Occupational Health setting.
Occupational Health services provide regular access to a large working population and may therefore offer an opportunity to improve access to diabetic retinopathy screening. Integrating such screening into Occupational Health could contribute to earlier detection of diabetic retinopathy and facilitate referral to appropriate ophthalmologic care when needed.
Workers with diabetes may be informed about the study during an Occupational Health visit or through a screening campaign conducted by the Occupational Health Department. Workers who wish to participate will receive information about the study and will attend a single inclusion and screening visit.
After informed consent, participants will undergo retinal photography using the FundusScope FC161 non-mydriatic retinal camera. The examination is non-invasive and does not require pupil dilation. Retinal images will subsequently be assessed by the Ophthalmology Department of Clermont-Ferrand University Hospital.
Participants will also complete a self-administered questionnaire, electronically using REDCap or on paper when necessary. The questionnaire will collect information on diabetes, sociodemographic and occupational characteristics, lifestyle factors, and several self-reported measures related to health and work.
Each participant will attend only one study visit, lasting approximately 30 minutes. Participants will be informed of their retinal screening results and, when necessary, will be referred to an appropriate care pathway.
The primary focus of the study is the acceptability of diabetic retinopathy screening in the Occupational Health setting. The study will also estimate the prevalence of diabetic retinopathy detected through the screening program and describe the characteristics of participating workers, including factors potentially associated with diabetic retinopathy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diabetic retinopathy screening | Experimental | Device: Non-mydriatic retinography; Other: Self-administered questionnaire | Participants will undergo retinophotography in the Occupational Health Department using the non-mydriatic retinograph FundusScope FC161. Participants will also complete a self-administered questionnaire, administered online via REDCap® or in paper version for individuals who may have difficulty using computers. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Worker * Adult (≥18 years old) * Diabetic * Affiliated with a Social Security scheme * Able to give informed consent to participate in the research Exclusion Criteria: * Protected persons (minors, guardianship, curatorship, deprived of freedoms, safeguard of justice) * Pregnant or breastfeeding women; these women may be offered participation after pregnancy and/or breastfeeding * Non-voluntary person
| Facility | City | Country | Status |
|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | France |