Association Between Dry Eye Disease and Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dry Eye Disease (DED) Symptom Severity
研究概览
简要总结
This study evaluates the association between dry eye disease (DED) and diabetic macular edema (DME) in adult patients at the Ophthalmology Department, Faculty of Medicine, Sohag University. Participants will undergo standardized assessments for dry eye and clinical evaluation for macular edema. The goal is to improve understanding of the relationship between these two eye conditions in patients with diabetes.
详细描述
This prospective observational cross-sectional study investigates the relationship between Dry Eye Disease (DED) and Diabetic Macular Edema (DME) in adult diabetic patients at the Ophthalmology Department, Faculty of Medicine, Sohag University.
Participants undergo comprehensive ocular assessments during a single baseline visit, including:
DED evaluation: Ocular Surface Disease Index (OSDI) questionnaire, tear film break-up time (TBUT), Schirmer test, and slit-lamp ocular surface examination.
DME assessment: Clinical fundus examination and Optical Coherence Tomography (OCT) imaging.
The study aims to identify associations between anterior segment (ocular surface) parameters and posterior segment pathology (macular edema), to improve understanding of diabetic ocular complications and inform future screening and management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years.
- •Confirmed diagnosis of diabetes mellitus >8 years.
- •Ability to undergo OCT examination.
- •Ability to perform standardized dry eye diagnostic tests.
- •Signed informed consent after explanation of study purpose.
排除标准
- •History of ocular surgery.
- •History of Argon laser photocoagulation.
- •Advanced proliferative diabetic retinopathy (PDR): tractional retinal detachment, vitreous hemorrhage, optic neuropathy.
- •Previous significant ocular trauma.
- •Presence of other ocular surface diseases, or history of systemic or ocular surgeries affecting the eye.
研究组 & 干预措施
Group 1: Participants with Diabetic Macular Edema (DME)
Participants diagnosed with DME. Dry Eye Disease (DED) will be assessed using imaging and clinical evaluation (OSDI questionnaire, TBUT, Schirmer test, ocular surface examination).
干预措施: Dry Eye Disease Assessment (Diagnostic Test)
Group 2: Participants without DME
Participants without DME. Dry Eye Disease (DED) will be assessed using imaging and clinical evaluation (OSDI questionnaire, TBUT, Schirmer test, ocular surface examination).
干预措施: Dry Eye Disease Assessment (Diagnostic Test)
结局指标
主要结局
Dry Eye Disease (DED) Symptom Severity
时间窗: Baseline (single visit)
DED symptoms will be assessed using the Ocular Surface Disease Index (OSDI) questionnaire to quantify ocular discomfort, visual disturbance, and functional limitations. Units of Measure: OSDI score (0-100)
Tear Film Function
时间窗: Baseline (single visit)
Tear film function will be evaluated using Tear Break-Up Time (TBUT) to measure tear film stability and the Schirmer test to assess tear production. Three consecutive measurements are averaged for TBUT; Schirmer test is performed over 5 minutes. Units of Measure: TBUT in seconds; Schirmer test in millimeters (mm)
Diabetic Macular Edema (DME) Severity
时间窗: Baseline (single visit)
Diabetic Macular Edema (DME) Severity Description: DME severity will be assessed by clinical fundus examination and Optical Coherence Tomography (OCT) imaging to determine the presence and severity of macular edema. Central macular thickness and retinal fluid are measured. Units of Measure: Macular thickness in micrometers (µm); clinical grading of edema.
次要结局
未报告次要终点
研究者
Esraa Aly
Resident doctor, Ophthalmology department, sohag teaching hospital
Sohag University