Home Monitoring of Diabetic Macular Edema
Macular Edema Due to Diabetes Mellitus
About this trial
This is an interventional treatment trial for Macular Edema Due to Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years;
Diagnosis of diabetic macular edema:
- Type 1 or type 2 diabetes mellitus;
- Center-involved macular edema;
- Willing to receive anti-VEGF treatment;
- Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT examination;
- Able to operate self-administratedhome OCT by themselves or with the help of family;
- Travel time from home to hospital: within 2 hours driving.
- Able and willing to provide informed consent.
Exclusion Criteria:
- History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. (These drugs should not be used during the study);
- History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months;
- History of macular laser photocoagulation in the past 4 months;
- Macular edema due to reasons other than diabetes;
- Coexisting ocular diseases that might alter visual acuity during the course of the study, such as retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.);
- Hypertension (systolic blood pressure (BP) above 180 or diastolic BP above 110);
- History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization;
- Pregnant or lactating;
- Currently participating in other clinical trials;
Sites / Locations
- Zhongshan Ophthalmic CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Home OCT monitoring model
Hospital-based monitoring with a staff-administrated OCT
Participants will receive a home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester. For each home service, participants will undergo the following: Smartphone-assisted online instruction provided by a virtual specialist Visual acuity self test using a smartphone Self-testing OCT imaging
Participants will be instructed to come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators every month.