Home Care Monitoring of Visual Acuity and OCT Versus Standard Hospital/Clinic Care Monitoring During Diabetic Macular Edema Management: A Non-inferiority Randomized Clinical Trial
Diabetic macular edema (DME) is a common cause of central visual loss in diabetic patients and a global public health burden around the world. Most patients with DME and vision loss require pharmacological inhibition using anti-VEGF agents with multiple monitoring visits that require both visual acuity testing and optical coherence tomography (OCT) to determine if re-treatment is warranted as well as the recommended time interval to the next follow-up visit. However, this treatment regimen often requires monthly or every other month clinic visits, which places a substantial burden on ophthalmic clinics and patients. Recently, portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases, e.g., DME, although these devices do not include visual acuity determination. The investigators previously proposed to deliver Home OCT devices and Home visual acuity tester to patients\' homes to complete routine monitoring visits at home. However, there is a lack of evidence regarding the safety and efficacy of this novel monitoring regimen for DME patients, specifically whether its use could reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes. This study aims to provide evidence to support use of a novel monitoring regimen for DME patients that could substantially reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.
⁃ To be eligible, the following inclusion criteria must be met:
• Age of 18 years or older;
• Type 1 or type 2 diabetes mellitus
• Current regular use of insulin for the treatment of diabetes or current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• Travel time from home to the hospital/clinic within a 2-hour driving distance
• At least one eye meets the study eye criteria listed in Section 2.4
• Ability and willingness to operate the self-administrated visual acuity tester and Home OCT device by themselves or with the help of family after training
• Ability and willingness to provide informed consent
• Central-involved DME (central subfield thickness on OCT defined on Heidelberg Spectralis OCT 320 μm or more in men and 305 μm or more in women, or Zeiss Cirrus OCT 305 μm or more in men and 290 μm or more in women, or the equivalent on spectral-domain OCT based on gender specific cutoffs)
• Best corrected visual acuity letter score ≤ 78 (i.e., 20/32 or worse) and ≥ 24 (i.e., 20/320 or better) within seven days of inclusion
• Received no treatment for DME before, or received no anti-VEGF injection for DME within the past 3 months; however, if there is a history of anti-VEGF injections, \<=1 injection in the past year and \<=3 injections over the study participant's lifetime); or, \<=2 monthly injections within the past 3 months and \<=3 injections over the past year, and \<=6 injections over the study participant's lifetime.
• Sufficient media clarity, pupillary dilation, and individual cooperation to allow for adequate fundus photographs and adequate OCT