An observational study in Dry Eye Disease (DED) , Diabetic Macular Edema, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Sohag University · Observational
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.
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.
The study design is cross-sectional (all assessments at a single visit) and prospective regarding enrollment and data collection at baseline.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
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50 patients with diabetes aged 18-60 years, including 25 patients with diabetic macular edema and 25 patients without macular edema.
Design : This cross-sectional observational study aims to assess ocular and systemic characteristics associated with diabetic macular edema
Exclusion Criteria:
Participants diagnosed with DME. Dry Eye Disease (DED) will be assessed using imaging and clinical evaluation (OSDI questionnaire, TBUT, Schirmer test, ocular surface examination).
Diagnostic Test: Dry Eye Disease Assessment
Participants without DME. Dry Eye Disease (DED) will be assessed using imaging and clinical evaluation (OSDI questionnaire, TBUT, Schirmer test, ocular surface examination).
Diagnostic Test: Dry Eye Disease Assessment
Assessment of dry eye symptoms, tear film function, and ocular surface examination using standardized questionnaires and clinical tests (OSDI, TBUT, Schirmer test).
Dry Eye Disease (DED) Symptom Severity
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)
Time frame: Baseline (single visit)
Tear Film Function
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)
Time frame: Baseline (single visit)
Diabetic Macular Edema (DME) Severity
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.
Time frame: Baseline (single visit)
Plan to share: Undecided — Plans to share Individual Participant Data (IPD) are currently undecided. Any future sharing will follow ethical approvals, institutional policies, and measures to protect participant confidentiality.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Sohag University