Ocular Discomfort Assessment After Intravitreal Injections

Evaluation de la gêne Oculaire après Injections intravitréennes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02806830

Acronym

EVAGO

Enrollment

Registered

2016-06-21

Start date

2016-04-30

Completion date

2017-07-01

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative

Keywords

Intravitreal injection, AMD, Diabetic Retinopathy, Retinal Artery Occlusion, Myopia, Degenerative, eye drops

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.

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.

Interventions

DRUGOptive

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026