Home Monitoring of Diabetic Macular Edema

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    Zhongshan Ophthalmic Center, Sun Yat-sen University
Updated on 6 April 2023


Diabetic macular edema (DME) is part of diabetic retinopathy (DR) and a leading cause of central visual loss in people with diabetes . Most patients require pharmacological inhibition using anti-vascular endothelial growth factor (VEGF) agents with multiple monitoring visits that include optical coherence tomography (OCT), visual acuity test, and multiple injections.The substantial visit frequency puts pressure on ophthalmic clinics, and can impose a tremendous burden on both patients and their caregivers. Therefore, self-service examination instruments that can be portable and fast-moving become the key for realizing Metaverse medicine. Recently, the investigators have developed a portable, self-administrated home OCT machine, which is designed for home-based OCT scanning and monitoring for patients with retinal diseases including DME, age related macular degeneration (AMD) and choroidal neovascularization (CNV) that require multiple anti-VEGF injections. The investigators have confirmed its image quality and validated the retinal thickness measurements obtained from this device by comparing with hospital OCT (staff-administrated and clinic-based).In this study, the investigators will conduct a randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a Metaverse-assisted home OCT monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-VEGF injections.

Condition Macular Edema Due to Diabetes Mellitus
Treatment Metaverse-assisted home OCT monitoring model, Hospital-based monitoring with a staff-administrated OCT
Clinical Study IdentifierNCT05223569
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
Last Modified on6 April 2023


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note