Ocular Discomfort Assessment After Intravitreal Injections (EVAGO)

Centre Hospitalier Intercommunal Creteil

Status: Completed

Conditions: Myopia, Degenerative; Retinal Artery Occlusion; Macular Degeneration; Diabetic Retinopathy

Treatments: Drug: Optive

Study type: Interventional

Funder types: Other

Identifiers

NCT02806830

EVAGO

Details and patient eligibility

About

In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.

Full description

In naive patients, the two first intravitreal injections will be studied. Within the first injection, no wetting agent will be delivered. Within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort.

After the second injection, a treatment with wetting agent will be prescribed. With 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18 years old
• Patient with social healthcare
• Patient understanding French language
• Patient requiring anti-VEGF treatment by intravitreal injection

Exclusion criteria

• Patient treated by Ozurdex® before
• Patient with known and treated ocular dryness
• Non naive patient for intravitreal injection
• Hypersensitivity to Carmellose
• Patient who received wetting agent within the 3 last months
• History of povidone-iodine allergy
• Pregnant or breastfeeding mother

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Optive after the second anti-VEGF injection

Experimental group

Description:

Naive patients requiring intravitreal injection. Patients will be enrolled in this study within the 2 first intravitreal injections to assess quality of life and ocular discomfort without wetting agent (ie after the first injection) and with wetting agent (ie after the second injection)

Treatment:

Drug: Optive