Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
- Conditions
- Neovascular Age-related Macular Degeneration
- Sponsor
- The New York Eye & Ear Infirmary
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Post Intravitreal Injection Measurement of Pain
- Last Updated
- 7 years ago
Overview
Brief Summary
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.
Detailed Description
This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment). Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.
Investigators
Ronald Gentile, MD
Professor
The New York Eye & Ear Infirmary
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Already scheduled for anti-VEGF injection based on standard of care for disease process.
- •Ability to provide written informed consent
- •Capable of complying with study protocol.
- •Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care
Exclusion Criteria
- •History of past intraocular injection of steroid medication.
- •Experiencing baseline eye pain
- •Monocular; non-study eye with VA\<20/
- •Unwilling or unable to follow or comply with all study related procedures
Arms & Interventions
A single drop of nepafenac 0.3% suspension
A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Intervention: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Patching
A light pressure patch applied for two hours
Intervention: patching
A single drop of preservative-free Artificial Tears
A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
Intervention: Theratears tear drop, (Akron, Ann 111 Arbor, MI)
Outcomes
Primary Outcomes
Post Intravitreal Injection Measurement of Pain
Time Frame: 6 hours and 24 hours after intravitreal injection
Change from Baseline post intravitreal injection pain at 6 and 24 hours as measured by the Numeric Pain Rating Scale. The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), at the screening, 6 hours and 24 hours.