Diabetic Macular Edema
Conditions
Brief summary
Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits
Interventions
OTHERtelemedecine follow-up
weekly home-based follow-up of visual acuity on electronic tablet
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Will be included in the study, patients with all of the following criteria: * aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes); * diagnosed with DME; * followed and treated by anti-VEGF IVT in the ophthalmology debarment at Hopital Saint Joseph Marseille; * having a VA score ≥ 20/100; * able to understand the study and to use a TC; * having an internet access at home; * having given free and informed written consent; * being affiliated with or benefiting from a social security scheme.
Exclusion criteria
Will not be included in the study, patients with one of the following criteria: * treated for another pathology that DME; * already participating to another research study; * pregnant or breastfeeding woman; * subject to a measure for the protection of justice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with VA evolution in the two groups | 36 months | rate in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital | 36 months | — |
| Number of follow-up and injection visits for each patient according to their group | 36 months | — |
| Average time between the follow-up visit and the IVT (if performed) | 36 months | in days |
| Variation of the VA measured using ETDRS scale on TC for the patients followed at home | 36 months | — |
| Change in quality of life for patients in group 1 compared to group 2 | 36 months | the quality of life is assessed with EQ-5D-5L questionnaire |
| Change in the total cost per patient for patient in group 1 compared to group 2. | 36 months | The total cost per patient is calculated from the number of follow-up visits, the number of procedures (OCT and fundus retinography) and the number of IVTs. |
| Variations in foveolar thickness and maximum central retinal thickness on OCT | 36 months | — |
Countries
France
Contacts
Primary ContactCecile Bielmann
Outcome results
None listed