EVAGO: Ocular Discomfort Assessment After Intravitreal Injections

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Completed

CT.gov ID

NCT02806830

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration Diabetic Retinopathy Retinal Artery Occlusion Myopia, Degenerative	Drug: Optive	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluation de la gêne Oculaire après Injections intravitréennes

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optive after the second anti-VEGF injection 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)	Drug: Optive Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days

Arm

Intervention/Treatment

Experimental: Optive after the second anti-VEGF injection

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)

Drug: Optive

Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days

Outcome Measures

Primary Outcome Measures

Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients [within the 72h after the first and the second intravitreal injections]