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Diabetic RetinopathyRETINOMEDNCT07828821

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

A study testing Non-mydriatic retinography and Self-administered questionnaire in people with Diabetic Retinopathy, run by University Hospital, Clermont-Ferrand at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Non-mydriatic retinography and Self-administered questionnaire
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteFrance
Study dates
Oct 2026to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Worker
  • Adult (≥18 years old)
  • Diabetic
  • Affiliated with a Social Security scheme
  • Able to give informed consent to participate in the research

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr

    Frédéric Dutheil

Other trials in France

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
Non-mydriatic retinography, Self-administered questionnaire
Keywords
Diabetic retinopathy, Diabetes, Occupational Health, Screening, Retinophotography
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-mydriatic retinographyDevice

    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 questionnaireOther

    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.

Study groups in NCT07828821
Study groupRoleWhat they receive
Diabetic retinopathy screeningExperimentalParticipants 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.
Receives: Device: Non-mydriatic retinography; Other: Self-administered questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

Secondary outcomes (44)
  1. Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers

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

    Measured: 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.

    Measured: Day 1

  3. Year of diabetes diagnosis

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

    Measured: Day 1

  4. Last HbA1c value

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

    Measured: Day 1

  5. Time since last HbA1c measurement

    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.

    Measured: Day 1

  6. Diabetes complications

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

    Measured: Day 1

  7. Time since last ophthalmological assessment

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

    Measured: Day 1

  8. Time since last cardiovascular assessment

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

    Measured: Day 1

  9. Antidiabetic treatment

    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.

    Measured: Day 1

  10. Age

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

    Measured: Day 1

  11. Gender

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

    Measured: Day 1

  12. Body mass index

    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.

    Measured: Day 1

  13. Family status

    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.

    Measured: Day 1

  14. Number of children

    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.

    Measured: Day 1

  15. Educational level

    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.

    Measured: Day 1

  16. Daily tobacco consumption

    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.

    Measured: Day 1

  17. Weekly alcohol consumption

    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.

    Measured: Day 1

  18. Leisure-time physical activity

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

    Measured: Day 1

  19. Occupational physical activity

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

    Measured: Day 1

  20. Total daily sitting time

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

    Measured: Day 1

  21. Daily sitting time at work

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

    Measured: Day 1

  22. Occupational status

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

    Measured: Day 1

  23. Sector of activity

    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.

    Measured: Day 1

  24. Weekly working time

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

    Measured: Day 1

  25. Daily working time

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

    Measured: Day 1

  26. Percentage of working time spent sitting

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

    Measured: Day 1

  27. Night work

    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.

    Measured: Day 1

  28. Number of weekends worked per month

    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.

    Measured: Day 1

  29. Telework

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

    Measured: Day 1

  30. Percentage of working time performed as telework

    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%.

    Measured: Day 1

  31. Job seniority

    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.

    Measured: Day 1

  32. Employment contract

    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.

    Measured: Day 1

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

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

    Measured: Day 1

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

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

    Measured: Day 1

  35. Fatigue assessed using a Visual Analog Scale

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

    Measured: Day 1

  36. Sleep quality assessed using a Visual Analog Scale

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

    Measured: Day 1

  37. Anxiety assessed using a Visual Analog Scale

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

    Measured: Day 1

  38. Mood assessed using a Visual Analog Scale

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

    Measured: Day 1

  39. Burnout assessed using a Visual Analog Scale

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

    Measured: Day 1

  40. Job control assessed using a Visual Analog Scale

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

    Measured: Day 1

  41. Job demand assessed using a Visual Analog Scale

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

    Measured: Day 1

  42. Support from hierarchy assessed using a Visual Analog Scale

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

    Measured: Day 1

  43. Support from colleagues assessed using a Visual Analog Scale

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

    Measured: Day 1

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

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07828821
Sponsor's protocol ID
RBHP 2025 DUTHEIL (RETINOMED)
Other IDs
2025-A02931-48
Acronym
RETINOMED
Status last verified
Sep 2026
First submitted
8 Sep 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Non-mydriatic retinography and Self-administered questionnaire in people with Diabetic Retinopathy, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (0473754963, promo_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?

Acceptability of diabetic retinopathy screening in an Occupational Health setting (time frame: Day 1). 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 18 Sep 2026.

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