Dry Eye Disease (DED) , Diabetic Macular Edema
Conditions
Keywords
Dry eye disease, Diabetic macular edema, Diabetes mellitus, Ocular surface, Optical coherence tomography (OCT), Ophthalmology
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDry 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).
Sponsors
Sohag University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dry Eye Disease (DED) Symptom Severity | 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 | 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 | 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. |
Countries
Egypt
Contacts
CONTACTEsraa A Ahmed, M.B.B.Ch
CONTACTMohamed I Hafez, MD, PhD
STUDY_DIRECTORIslam A Ahmed, MD,PhD
Sohag University, Faculty of Medicine
Outcome results
None listed