Clinical trial NCT02806830: Ocular Discomfort Assessment After Intravitreal Injections
Official title: Evaluation de la gêne Oculaire après Injections intravitréennes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Diabetic Retinopathy
Retinal Artery Occlusion
Myopia, Degenerative
Keywords: Intravitreal injection
AMD
Diabetic Retinopathy
Retinal Artery Occlusion
Myopia, Degenerative
eye drops
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients
timeFrame: within the 72h after the first and the second intravitreal injections
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Chi Creteil
Study officials:
affiliation: CHI Créteil
name: Oudy SEMOUN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nghiem-Buffet S, Cohen SY. [Retinal vein occlusion: anti-VEGF treatments]. J Fr Ophtalmol. 2009 Nov;32(9):679-86. doi: 10.1016/j.jfo.2009.10.002. Epub 2009 Oct 29. French.
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citation: Stewart MW. The clinical utility of aflibercept for diabetic macular edema. Diabetes Metab Syndr Obes. 2015 Sep 18;8:473-82. doi: 10.2147/DMSO.S72792. eCollection 2015.
citation: Massamba N, Elluard M, Agoune W, Guyader V, Ingram A, Pasquier B, Knoeri J. Assessment of ocular pain following ranibizumab intravitreal injection. Acta Ophthalmol. 2015 May;93(3):e231-2. doi: 10.1111/aos.12531. Epub 2014 Aug 13. No abstract available.
citation: Meyer CH, Krohne TU, Charbel Issa P, Liu Z, Holz FG. Routes for Drug Delivery to the Eye and Retina: Intravitreal Injections. Dev Ophthalmol. 2016;55:63-70. doi: 10.1159/000431143. Epub 2015 Oct 26.