Screening for Diabetic RETINopathy Using a Non-mydriatic Retinograph Funduscope in Occupational MEDicine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Worker

Adult (≥18 years old)

Diabetic

Affiliated with a Social Security scheme

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Non-mydriatic retinography

    Device

    Retinophotography will be performed using the non-mydriatic retinograph FundusScope FC161. The retinal images will subsequently be analyzed by the Ophthalmology Department. Screened workers will be informed of their results and will be redirected to the care pathway if necessary.

  • Self-administered questionnaire

    Other intervention

    Participants will complete a self-administered questionnaire, administered online via REDCap® or in paper version for individuals who may have difficulty using computers. The questionnaire will collect information about diabetes, occupational characteristics, sociodemographic characteristics, visual analog scales of stress at work, stress at home, anxiety, sleep quality, fatigue, mood/morale, burnout, autonomy at work, workload, support from the hierarchy, support from colleagues and satisfaction at work in relation to efforts deployed, and lifestyle variables including sitting, physical activity, alcohol and tobacco.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Diabetic retinopathy screeningExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Acceptability of diabetic retinopathy screening in an Occupational Health setting

Proportion of eligible workers who consent to undergo the proposed retinal screening during their Occupational Health visit.

Time frame
Day 1

Secondary outcomes

1

Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers

Proportion of screened diabetic workers with diabetic retinopathy detected by retinophotography.

Time frame
Day 1
2

Type of diabetes

Type of diabetes (type 1, type 2, or other), assessed using the self-administered questionnaire. Results will be reported as the percentage of participants in each category.

Time frame
Day 1
3

Year of diabetes diagnosis

Year of discovery of diabetes, assessed using the self-administered questionnaire. The measurement unit is calendar year.

Time frame
Day 1
4

Last HbA1c value

Last HbA1c value, assessed using the self-administered questionnaire. HbA1c is reported as a percentage (%).

Time frame
Day 1

Other outcomes

Sponsors and contacts

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