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

NCT07828821 | Not Yet Recruiting

• 2 other identifiers: RBHP 2025 DUTHEIL (RETINOMED)2025-A02931-48
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy; Diabetes; Occupational Health; Screening; Retinophotography

Outcome Measures

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.

  Day 1

Secondary Outcomes (44)

• Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers

  Day 1

• Type of diabetes

  Day 1

• Year of diabetes diagnosis

  Day 1

• Last HbA1c value

  Day 1

• Time since last HbA1c measurement

  Day 1

Study Arms (1)

Diabetic retinopathy screening

EXPERIMENTAL

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.

Device: Non-mydriatic retinography; Other: Self-administered questionnaire

Interventions

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.

Diabetic retinopathy screening

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.

Diabetic retinopathy screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Frédéric Dutheil

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)