Ocular Discomfort Assessment After Intravitreal Injections

Not Applicable

Completed

• Conditions: Myopia, Degenerative; Diabetic Retinopathy; Retinal Artery Occlusion; Macular Degeneration
• Interventions: Drug: Optive

• Registration Number: NCT02806830
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Primary Completion: 2017-01
• Status Verified: 2017-07
• Study Completion: 2017-07-01
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optive after the second anti-VEGF injection	Optive	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chi Creteil; 🇫🇷 Creteil, France