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

NCT ID: NCT04776343

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2024-04-30

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

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Telemedecine follow-up

Group Type: EXPERIMENTAL

telemedecine follow-up

Intervention Type: OTHER

weekly home-based follow-up of visual acuity on electronic tablet

Hospital follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telemedecine follow-up

weekly home-based follow-up of visual acuity on electronic tablet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Saint Joseph Marseille

Marseille, , France

Countries

France

Central Contacts

Cecile Bielmann

Role: CONTACT

cbielmann@hopital-saint-joseph.fr

0033 (0)4 88 73 10 70

Facility Contacts

Cécile Bielmann

Role: primary

Other Identifiers

2020_06_02

Identifier Type: -

Identifier Source: org_study_id