NCT07392307

Association Between Dry Eye Disease and Diabetic Macular Edema

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease (DED) , Diabetic Macular Edema

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-04-30
• Completion: 2026-10-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Egypt