NCT05223569

Home Monitoring of Diabetic Macular Edema

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Macular Edema Due to Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Home OCT monitoring model	A home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester
DEVICE	Hospital-based monitoring with a staff-administrated OCT	Participants come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators

Timeline

• Start date: 2022-03-03
• Primary completion: 2023-12-12
• Completion: 2024-06-01
• First posted: 2022-02-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: China