Intravitreal Injection, Pain, Pain, Acute
Conditions
Brief summary
The purpose of this prospective interventional study is to compare post-intravitreal injection pain between eyes receiving topical bromfenac versus artificial tears as an analgesic after intravitreal injection.
Detailed description
This proposed study is a double-masked randomized trial of adult patients receiving bilateral intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.
Interventions
DRUGUse of bromfenac 0.09% to reduce intravitreal injection pain
The eyedrop (bromfenac) will be given to the assigned eye.
DRUGUse of artificial tears to reduce intravitreal injection pain
The eyedrop (artificial tears) will be given to the assigned eye.
Sponsors
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients will be masked. The assistant instilling the eyedrop will be masked to which eyedrop is used for each eye.
Intervention model description
All patients will receive both bromfenac 0.09% in the study eye and artificial tears in the control eye. Patients will be randomized to determine whether their right or left eye is the study eye.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
are: * Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices * Clinical indication of bilateral intravitreal anti-vascular endothelial growth factor (VEGF) injection as determined by the treating retina specialist for diseases such as age-related macular degeneration, choroidal neovascularization, diabetic macular edema, diabetic retinopathy, macular edema. proliferative retinopathy, or macular edema associated with retina vein occlusion. * Age greater than 18 * Patient's that have had at least three prior injections in each eye
Exclusion criteria
are: * Prior ocular surgery (non-cataract) * Herpetic eye disease * Uncontrolled uveitis * Active conjunctivitis, keratitis or keratopathy * Current unilateral use of prescription eye drops. * Allergy to NSAID
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score | Patients will be asked in the office for their pain rating 5 minutes after injection | Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level. |
| Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale | Patients will be asked in the office for their pain rating 5 minutes after injection | Patients will be asked to report their pain on the Wong-Baker Faces pain scale, ranging from 0 through 10, in which 10 is the worst pain level. |
| Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score. | Patients will be called for their rating 6 hours after injection | Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level. |
| Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score. | Patients will be called for their rating 24 hours after injection | Patients will be asked to report their pain on the Short Form McGill Pain Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level. |
Countries
Canada, United States
Outcome results
None listed