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 tele-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 home OCT monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-VEGF injections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
A home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester
Participants come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
RECRUITINGChanges in visual acuity
Changes in visual acuity from baseline to 12 weeks adjusted for baseline visual acuity
Time frame: 12 weeks
The costs of treatment
The Cost-effectiveness between the two monitoring models
Time frame: 12 weeks
Number of intravitreal injections
The number of intravitreal injections given per group
Time frame: 12 weeks
Gains or losses in visual acuity
The proportion of eyes with two- and three-line gains or losses in visual acuity
Time frame: 12 weeks
Central subfield thickness change as measured by optical coherence tomography
central subfield thickness and retinal volume as measured by OCT after 12 weeks
Time frame: 12 weeks
Number of visits
The number of visits during the study
Time frame: 12 weeks
Changes in visual acuity after 24 weeks
Changes in visual acuity from baseline to 24 weeks adjusted for baseline visual acuity
Time frame: 24 weeks
Changes in visual acuity after 48 weeks
Changes in visual acuity from baseline to 48 weeks adjusted for baseline visual acuity
Time frame: 48 weeks
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