Status:
COMPLETED
Etude de l'ANesthésie Par Gel de Lidocaïne Pour Les Injections IntrA vitréennes
Lead Sponsor:
Institut Ophtalmologique de l'Ouest Jules Verne
Conditions:
Retinal Diseases - AMD - PAIN - Intravitreal Injection
Eligibility:
All Genders
18+ years
Brief Summary
Purpose To assess the efficacy of preservative-free Lidocaine gel 2% (LG) in patients complaining of pain during intravitreal injection (IVI) despite standard topical anaesthesia. Methods First phase...
Detailed Description
Introduction Déterminer l'efficacité d'une anesthésie topique par gel de Lidocaine à 2% (GL) à la place de l'oxybuprocaine chez les patients se plaignant d'une douleur importante lors des injections i...
Eligibility Criteria
Inclusion
- Patient with a VAS score during the 1st assessment: VAS ≥ 4/10
- Patients who have given their consent to switch to the protocol with the addition of lidocaine gel (information letter provided and collection of non-objection)
Exclusion
- Persons cited in articles L.1121-6 to L.1121-8 of the CSP
- Patients not followed at the IOO Jules Verne or at the Hauts Pavés practice.
- Eye pain before the procedure
- Intravitreal injections performed with oftriamcinolone acetonide
- Intravitreal injections performed with a larger gauge needle (Ozurdex® or Iluvien ®)
- Intravitreal injections performed using a disinfectant other than povidone iodine
- Patients for whom the protocol with lidocaine gel in anesthesia is already used
- Any cortisone injection
- Any uveitic inflammatory pathology whether immunological or infectious
- Anyone under systemic treatment with cortisone or morphine and its derivatives
Key Trial Info
Start Date :
June 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 5 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06493136
Start Date
June 13 2022
End Date
February 5 2023
Last Update
July 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Ophtalmologique de l'Ouest Jules Verne
Nantes, Loire Atlantique, France, 44300