Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity

Hospital Saint Joseph

Status: Unknown

Conditions: Diabetic Macular Edema

Treatments: Other: telemedecine follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04776343

2020_06_02

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Telemedecine follow-up

Experimental group

Treatment:

Other: telemedecine follow-up

Hospital follow-up

No Intervention group