Diabetic Macular Edema
Conditions
Interventions
Observation group:None
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Confirmed diagnosis of type 1 or type 2 diabetes mellitus, with HbA1c = 325 µm in the study eye. 4. BCVA of the study eye is between 0.3 LogMAR and 1.2 LogMAR (approximately equivalent to 0.06–0.5 on the decimal visual acuity chart). If both eyes meet eligibility criteria, the eye with worse baseline visual acuity shall be selected as the study eye; if visual acuity is equal, the eye with thicker CST shall be chosen. 5. Clear refractive media and sufficient pupillary dilation to obtain high-quality imaging results.
Exclusion criteria
Exclusion criteria: 1. Presence of other vision-affecting ocular diseases apart from diabetic retinopathy, refractive error and cataract. 2. Patients with severe systemic diseases or unstable medical conditions. 3. Poorly controlled hypertension, defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg confirmed by the investigator. (Inclusion may be considered if blood pressure can be stably controlled below these thresholds with antihypertensive treatment.) 4. Received intraocular corticosteroids within 6 months before enrollment, or periocular or systemic corticosteroids within 3 months before baseline. 5. History of intraocular surgery other than cataract surgery. 6. Received laser photocoagulation therapy within 3 months prior to enrollment or during the study period. 7. Pregnancy or lactation, or planned pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity;Central Subfield Thickness;Intraretinal Fluid;Subretinal Fluid;Hyperreflective Foci;Epiretinal Membrane;Diabetic Retinopathy Severity Scale ;Vascular Endothelial Growth Factor A;Interleukin 6;Angiopoietin-2; | — |
Countries
China
Contacts
Public ContactHuan Li
Hebei Eye Hospital
Outcome results
None listed