Phase 4
N=46
Control of Pain in Intravitreal Injections Using Topical NSAIDs
Intravitreal Injections · IVI
Bottom Line
View on ClinicalTrials.gov: NCT04343222 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: McGill Pain Questionnaire (SF-MPQ) Scores at Baseline — 0.62; 0.93; 0.53 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bromfenac (Drug); Artificial tears (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY McGill Pain Questionnaire (SF-MPQ) Scores at Baseline |
0.62; 0.93; 0.53 | — |
| PRIMARY McGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection |
0.50; 0.13; 0.13 | — |
| PRIMARY McGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection |
0; 0; 0 | — |
| PRIMARY Wong-Baker FACES Pain Scale Scores at Baseline |
0.75; 1.13; 0.53 | — |
| PRIMARY Wong-Baker FACES Pain Scale Scores at 6 Hours Post Injection |
0.53; 0.07; 0.13 | — |
| PRIMARY Wong-Baker FACES Pain Scale Scores at 24 Hours Post Injection |
0; 0; 0 | — |
Summary
Intravitreal injections (IVI) are a common form of treatment for multiple retinal pathologies. The investigators hypothesize that an intervention with a topical NSAID will alleviate pain experienced at intravitreal injection (IVI) and post-IVI. 46 participants will be recruited, randomized into 1 of 3 treatment arms, and can expect to be on study for a day.
Eligibility Criteria
Inclusion Criteria
- Eyes with retinal pathology requiring anti-VEGF therapy
- Previously had an IVI
Exclusion Criteria
- History of previous eye surgery other than cataract extraction
- Herpetic eye disease
- Uncontrolled glaucoma
- Uveitis
- Acute conjunctivitis
- Pregnancy
- Known previous adverse response or contraindication to intravitreal injection, Bromfenac, or other NSAIDs.
- Keratitis including povidone-induced keratitis
- Bullous keratopathy
- Diagnosis of dry eye syndrome
- Uncontrolled diabetes
- NSAID use 3 days prior to IVI
Data sourced from ClinicalTrials.gov (NCT04343222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.