Association Between Dry Eye Disease and Diabetic Macular Edema (DED-DME)

February 4, 2026 updated by: Esraa Aly, Sohag University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed I Hafez, MD, PhD
  • Phone Number: +201068559840

Study Locations

  • Egypt
    • Egypt
      • Sohag, Egypt, Egypt, 82524

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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).
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (single visit)
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)
Baseline (single visit)
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.
Baseline (single visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Islam A Ahmed, MD,PhD, Sohag University, Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Manaviat MR, Rashidi M, Afkhami-Ardekani M, Shoja MR. Prevalence of dry eye syndrome and diabetic retinopathy in type 2 diabetic patients. BMC Ophthalmology. 2008;8:10.
  • Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. The Ocular Surface. 2017;15(3):276-283.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Disease (DED) , Diabetic Macular Edema

Clinical Trials on Dry Eye Disease Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe