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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry Eye Disease Assessment | Diagnostic Test | Assessment of dry eye symptoms, tear film function, and ocular surface examination using standardized questionnaires and clinical tests (OSDI, TBUT, Schirmer test). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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. | Baseline (single visit) |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa A Ahmed, M.B.B.Ch | Contact | +201022649668 | esraaaly@med.sohag.edu.eg | |
| Mohamed I Hafez, MD, PhD | Contact | +201068559840 |
| Name | Affiliation | Role |
|---|---|---|
| Islam A Ahmed, MD,PhD | Sohag University, Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag university | Sohag | Egypt | 82524 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18513455 | Background | Manaviat MR, Rashidi M, Afkhami-Ardekani M, Shoja MR. Prevalence of dry eye syndrome and diabetic retinopathy in type 2 diabetic patients. BMC Ophthalmol. 2008 Jun 2;8:10. doi: 10.1186/1471-2415-8-10. | |
| 28736335 | Background | Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. |
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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.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |