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Clinical Trials/NCT02806830
NCT02806830
Completed
Not Applicable

Evaluation de la gêne Oculaire après Injections intravitréennes

Centre Hospitalier Intercommunal Creteil1 site in 1 country45 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Optive
Conditions
Macular Degeneration
Sponsor
Centre Hospitalier Intercommunal Creteil
Enrollment
45
Locations
1
Primary Endpoint
Comparison of the overall scores of the ocular discomfort questionnaire after the 2 first intravitreal injection in naïve patients
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
July 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Oudy SEMOUN

Doctor in ophtalmology

Centre Hospitalier Intercommunal Creteil

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

Arms & Interventions

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)

Intervention: Optive

Outcomes

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

Study Sites (1)

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