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NCT Number: NCT07828821

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

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location contact

Frédéric Dutheil

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

0473754963

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Acceptability of diabetic retinopathy screening in an Occupational Health setting

    Time frame: Day 1

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

Secondary outcomes

  1. Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers

    Time frame: Day 1

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

  2. Type of diabetes

    Time frame: Day 1

    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.

  3. Year of diabetes diagnosis

    Time frame: Day 1

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

  4. Last HbA1c value

    Time frame: Day 1

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

  5. Time since last HbA1c measurement

    Time frame: Day 1

    Time since the last HbA1c measurement assessed using the self-administered questionnaire. Categories are 1 month, 2 months, 3 months, 4 to 6 months, more than 6 months, and more than 1 year. Results will be reported as the percentage (%) of participants in each category.

  6. Diabetes complications

    Time frame: Day 1

    Presence of diabetes complications, assessed using the self-administered questionnaire. Diabetes complications are reported by participants in a free-text field.

  7. Time since last ophthalmological assessment

    Time frame: Day 1

    Time since the participant's last ophthalmological assessment, assessed using the self-administered questionnaire and expressed in months.

  8. Time since last cardiovascular assessment

    Time frame: Day 1

    Time since the participant's last cardiovascular assessment, assessed using the self-administered questionnaire and expressed in months.

  9. Antidiabetic treatment

    Time frame: Day 1

    Antidiabetic treatment assessed using the self-administered questionnaire. Categories include insulin, oral antidiabetic treatment, physical activity, diet, and other treatment. Multiple responses are possible. Results will be reported as the percentage (%) of participants reporting each category.

  10. Age

    Time frame: Day 1

    Age assessed using the self-administered questionnaire and expressed in years.

  11. Gender

    Time frame: Day 1

    Grnder assessed using the self-administered questionnaire. Categories are female and male. Results will be reported as the percentage (%) of participants in each category.

  12. Body mass index

    Time frame: Day 1

    Body mass index calculated from self-reported height in centimeters and weight in kilograms collected using the questionnaire. Body mass index is expressed in kg/m².

  13. Family status

    Time frame: Day 1

    Family status assessed using the self-administered questionnaire. Categories are living as a couple and single. Results will be reported as the percentage (%) of participants in each category.

  14. Number of children

    Time frame: Day 1

    Number of children assessed using the self-administered questionnaire. Categories are none, 1, 2, and 3 or more children. Results will be reported as the percentage (%) of participants in each category.

  15. Educational level

    Time frame: Day 1

    Educational level assessed using the self-administered questionnaire. Categories are " ≤ brevet des collèges , CAP/BEP , Bac , Bac+1/+4 , Bac+5 and >Bac+5" Results will be reported as the percentage (%) of participants in each category.

  16. Daily tobacco consumption

    Time frame: Day 1

    Number of cigarettes smoked per day assessed using the self-administered questionnaire. Categories are 0, 1-4, 5-9, 10-14, 15-19, and >20 cigarettes per day. Results will be reported as the percentage (%) of participants in each category.

  17. Weekly alcohol consumption

    Time frame: Day 1

    Number of alcoholic drinks consumed per week assessed using the self-administered questionnaire. Categories are 0, 1-4, 5-9, 10-14, 15-19, and >20 drinks per week. Results will be reported as the percentage (%) of participants in each category.

  18. Leisure-time physical activity

    Time frame: Day 1

    Duration of leisure-time physical activity assessed using the self-administered questionnaire and expressed in hours per week.

  19. Occupational physical activity

    Time frame: Day 1

    Duration of physical activity at work assessed using the self-administered questionnaire and expressed in hours per week.

  20. Total daily sitting time

    Time frame: Day 1

    Total sitting time assessed using the self-administered questionnaire and expressed in hours per day.

  21. Daily sitting time at work

    Time frame: Day 1

    Sitting time at work assessed using the self-administered questionnaire and expressed in hours per day.

  22. Occupational status

    Time frame: Day 1

    Current or last occupational status assessed using the self-administered questionnaire. Results will be reported as the percentage (%) of participants in each occupational category.

  23. Sector of activity

    Time frame: Day 1

    Current or last sector of activity assessed using the self-administered questionnaire. Results will be reported as the percentage (%) of participants in each sector of activity.

  24. Weekly working time

    Time frame: Day 1

    Number of hours worked per week assessed using the self-administered questionnaire and expressed in hours per week.

  25. Daily working time

    Time frame: Day 1

    Number of hours worked per working day assessed using the self-administered questionnaire and expressed in hours per working day.

  26. Percentage of working time spent sitting

    Time frame: Day 1

    Proportion of working time spent sitting assessed using the self-administered questionnaire and expressed as a percentage (%).

  27. Night work

    Time frame: Day 1

    Night work assessed using the self-administered questionnaire. Categories are no night work, fixed night work, shift work, variable or occasional night work, and other. Results will be reported as the percentage (%) of participants in each category.

  28. Number of weekends worked per month

    Time frame: Day 1

    Number of weekends worked per month assessed using the self-administered questionnaire. Categories are 0, 1, 2, 3, and 4 or more weekends per month. Results will be reported as the percentage (%) of participants in each category.

  29. Telework

    Time frame: Day 1

    Telework assessed using the self-administered questionnaire as yes or no. Results will be reported as the percentage (%) of participants reporting telework.

  30. Percentage of working time performed as telework

    Time frame: Day 1

    Percentage of working time performed as telework among participants reporting telework, assessed using the self-administered questionnaire. Categories are <20%, 21-40%, 41-60%, 61-80%, and >80%.

  31. Job seniority

    Time frame: Day 1

    Seniority in the current position assessed using the self-administered questionnaire. Categories are <6 months, 6 months to 1 year, 1-3 years, 3-5 years, 5-10 years, and >10 years. Results will be reported as the percentage (%) of participants in each category.

  32. Employment contract

    Time frame: Day 1

    Employment contract assessed using the self-administered questionnaire. Categories are fixed-term contract, permanent contract or tenured position, work-study contract, temporary employment, and other. Results will be reported as the percentage (%) of participants in each category.

  33. Work-related stress assessed using a Visual Analog Scale

    Time frame: Day 1

    Work-related stress assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  34. Home-related stress assessed using a Visual Analog Scale

    Time frame: Day 1

    Home-related stress assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum)

  35. Fatigue assessed using a Visual Analog Scale

    Time frame: Day 1

    Fatigue assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  36. Sleep quality assessed using a Visual Analog Scale

    Time frame: Day 1

    Sleep quality assessed using a Visual Analog Scale (VAS) ranging from 0 (poor) to 100 (excellent).

  37. Anxiety assessed using a Visual Analog Scale

    Time frame: Day 1

    Anxiety assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  38. Mood assessed using a Visual Analog Scale

    Time frame: Day 1

    Mood assessed using a Visual Analog Scale (VAS) ranging from 0 (poor) to 100 (excellent).

  39. Burnout assessed using a Visual Analog Scale

    Time frame: Day 1

    Burnout assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  40. Job control assessed using a Visual Analog Scale

    Time frame: Day 1

    Job control assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  41. Job demand assessed using a Visual Analog Scale

    Time frame: Day 1

    Job demand assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  42. Support from hierarchy assessed using a Visual Analog Scale

    Time frame: Day 1

    Support from hierarchy assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  43. Support from colleagues assessed using a Visual Analog Scale

    Time frame: Day 1

    Support from colleagues assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

  44. Job satisfaction in relation to efforts assessed using a Visual Analog Scale

    Time frame: Day 1

    Job satisfaction in relation to efforts made at work assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

0473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: RETINOMED

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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