Clinical trial NCT06130384: Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
Official title: Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Intravitreal Injection
Pain, Acute
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
timeFrame: Patients will be asked in the office for their pain rating 5 minutes after injection
measure: Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
timeFrame: Patients will be asked in the office for their pain rating 5 minutes after injection
measure: Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
timeFrame: Patients will be called for their rating 6 hours after injection
measure: Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
timeFrame: Patients will be called for their rating 6 hours after injection
measure: Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
timeFrame: Patients will be called for their rating 24 hours after injection
measure: Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
timeFrame: Patients will be called for their rating 24 hours after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Bethlehem
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: San Antonio
country: United States
facility: Retina Consultants of San Antonio
state: Texas
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References: