Dry Eye Disease (DED) , Diabetic Macular EdemaDED-DMENCT07392307
Association Between Dry Eye Disease and Diabetic Macular Edema
An observational study of Dry Eye Disease (DED) , Diabetic Macular Edema, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dry Eye Disease (DED) , Diabetic Macular Edema
- What is being tested?
- Dry Eye Disease Assessment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed I Hafez, MD, PhD contact
Egypt1 site
Sohag university
Sohag, Egypt, 82524
Esraa A Ahmed, M.B.B.Ch, +201022649668, esraaaly@med.sohag.edu.eg
About this study
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.
Read the 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.
- Being tested
- Dry Eye Disease Assessment
- Keywords
- Dry eye disease, Diabetic macular edema, Diabetes mellitus, Ocular surface, Optical coherence tomography (OCT), Ophthalmology
- Medical subject headings
- Dry Eye Syndromes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Eye Disease AssessmentDiagnostic test
Assessment of dry eye symptoms, tear film function, and ocular surface examination using standardized questionnaires and clinical tests (OSDI, TBUT, Schirmer test).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Dry Eye Disease Assessment | |
| 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). Receives: Diagnostic Test: Dry Eye Disease Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: Baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED) , Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Aly, Sohag University
- Investigators
- Islam A Ahmed, MD,PhD, Study director, Sohag University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392307
- Sponsor's protocol ID
- EAly
- Acronym
- DED-DME
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 18513455Craig 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.
PubMed 28736335
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dry Eye Disease and Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07392307
- Acronym / sponsor ID
- DED-DME / EAly
- Keywords
- Dry eye disease, Diabetic macular edema, Diabetes mellitus, Ocular surface, Optical coherence tomography (OCT), Ophthalmology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants with Diabetic Macular Edema (DME) | – | Diagnostic Test: Dry Eye Disease AssessmentParticipants 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 | – | Diagnostic Test: Dry Eye Disease AssessmentParticipants without DME. Dry Eye Disease (DED) will be assessed using imaging and clinical evaluation (OSDI questionnaire, TBUT, Schirmer test, ocular surface examination). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Eye Disease AssessmentAssessment of dry eye symptoms, tear film function, and ocular surface examination using standardized questionnaires and clinical tests (OSDI, TBUT, Schirmer test). | Diagnostic test | Group 1: Participants with Diabetic Macular Edema (DME), Group 2: Participants without DME |
Primary outcome
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)
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 18513455Manaviat 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.
- Background: PubMed 28736335Craig 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.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed I Hafez, MD, PhD contact
Islam A Ahmed, MD,PhD study director
Sohag University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease (DED) , Diabetic Macular Edema, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa A Ahmed, M.B.B.Ch (+201022649668, esraaaly@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry Eye Disease (DED) Symptom Severity (time frame: Baseline (single visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07392307, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.