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NCT Number: NCT07392307

Association Between Dry Eye Disease and Diabetic Macular Edema

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.

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Key information

Conditions

Dry Eye Disease (DED) , Diabetic Macular Edema Diabetes Mellitus Dry Eye Syndromes Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Lacrimal Apparatus Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Dry Eye Disease (DED) Symptom Severity

    Time frame: 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)

  2. Tear Film Function

    Time frame: 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)

  3. Diabetic Macular Edema (DME) Severity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa A Ahmed, M.B.B.Ch

CONTACT

[email protected]

+201022649668

Mohamed I Hafez, MD, PhD

CONTACT

+201068559840

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Acronym: DED-DME

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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