Association Between Dry Eye Disease and Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dry Eye Disease Assessment.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED) , Diabetic Macular Edema. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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).
Primary outcome measures
- Dry Eye Disease (DED) Symptom Severity [Time frame: Baseline (single visit)]
- Tear Film Function [Time frame: Baseline (single visit)]
- Diabetic Macular Edema (DME) Severity [Time frame: Baseline (single visit)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Egypt · 1 center
- Sohag university — Sohag
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. PMID 18513455
- 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. PMID 28736335
Identifiers
NCT: NCT07392307 · EAly