Screening for Diabetic RETINopathy Using a Non-mydriatic Retinograph Funduscope in Occupational MEDicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Acceptability of diabetic retinopathy screening in an Occupational Health setting
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years old)
- •Affiliated with a Social Security scheme
- •Able to give informed consent to participate in the research
排除标准
- •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
研究组 & 干预措施
Diabetic retinopathy screening
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.
干预措施: Non-mydriatic retinography (Device)
Diabetic retinopathy screening
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.
干预措施: Self-administered questionnaire (Other)
结局指标
主要结局
Acceptability of diabetic retinopathy screening in an Occupational Health setting
时间窗: Day 1
Proportion of eligible workers who consent to undergo the proposed retinal screening during their Occupational Health visit.
次要结局
- Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers(Day 1)
- Type of diabetes(Day 1)
- Year of diabetes diagnosis(Day 1)
- Age(Day 1)
- Last HbA1c value(Day 1)
- Time since last HbA1c measurement(Day 1)
- Diabetes complications(Day 1)
- Time since last ophthalmological assessment(Day 1)
- Time since last cardiovascular assessment(Day 1)
- Antidiabetic treatment(Day 1)
- Gender(Day 1)
- Body mass index(Day 1)
- Family status(Day 1)
- Number of children(Day 1)
- Educational level(Day 1)
- Daily tobacco consumption(Day 1)
- Weekly alcohol consumption(Day 1)
- Leisure-time physical activity(Day 1)
- Occupational physical activity(Day 1)
- Total daily sitting time(Day 1)
- Daily sitting time at work(Day 1)
- Occupational status(Day 1)
- Sector of activity(Day 1)
- Weekly working time(Day 1)
- Daily working time(Day 1)
- Percentage of working time spent sitting(Day 1)
- Night work(Day 1)
- Number of weekends worked per month(Day 1)
- Telework(Day 1)
- Percentage of working time performed as telework(Day 1)
- Job seniority(Day 1)
- Employment contract(Day 1)
- Work-related stress assessed using a Visual Analog Scale(Day 1)
- Home-related stress assessed using a Visual Analog Scale(Day 1)
- Fatigue assessed using a Visual Analog Scale(Day 1)
- Sleep quality assessed using a Visual Analog Scale(Day 1)
- Anxiety assessed using a Visual Analog Scale(Day 1)
- Mood assessed using a Visual Analog Scale(Day 1)
- Burnout assessed using a Visual Analog Scale(Day 1)
- Job control assessed using a Visual Analog Scale(Day 1)
- Job demand assessed using a Visual Analog Scale(Day 1)
- Support from hierarchy assessed using a Visual Analog Scale(Day 1)
- Support from colleagues assessed using a Visual Analog Scale(Day 1)
- Job satisfaction in relation to efforts assessed using a Visual Analog Scale(Day 1)