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Ocular Discomfort Assessment After Intravitreal Injections (EVAGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02806830
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Oudy SEMOUN, 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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Diabetic Retinopathy Retinal Artery Occlusion Myopia, Degenerative Drug: Optive Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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 : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02806830

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Chi Creteil
Creteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Principal Investigator: Oudy SEMOUN, MD CHI Créteil


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Responsible Party: Oudy SEMOUN, Doctor in ophtalmology, Centre Hospitalier Intercommunal Creteil Identifier: NCT02806830    
Other Study ID Numbers: EVAGO
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Oudy SEMOUN, Centre Hospitalier Intercommunal Creteil:
Intravitreal injection
Diabetic Retinopathy
Retinal Artery Occlusion
Myopia, Degenerative
eye drops
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Retinal Artery Occlusion
Myopia, Degenerative
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Refractive Errors
Arterial Occlusive Diseases