Ocular Discomfort Assessment After Intravitreal Injections

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.

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Key information

Conditions

Macular Degeneration Arterial Occlusive Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Myopia Myopia, Degenerative Refractive Errors Retinal Artery Occlusion Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chi Creteil

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optive

Drug

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

Primary outcomes

Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients

Time frame: within the 72h after the first and the second intravitreal injections

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

Evaluation de la gêne Oculaire après Injections intravitréennes

Acronym: EVAGO

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 21, 2016
Registry last updated: Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed