Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.

Conditions
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Pain, Intravitreal Injection, Pain, Acute

Intervention / Treatment
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* Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain
* Drug: Use of artificial tears to reduce intravitreal injection pain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromfenac 0.09%<br>At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent. | Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain<br>* The eyedrop (bromfenac) will be given to the assigned eye.<br>|
| Placebo Comparator: Artificial Tear<br>At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent. | Drug: Use of artificial tears to reduce intravitreal injection pain<br>* The eyedrop (artificial tears) will be given to the assigned eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post-injection pain at 5 minutes using the Short Form McGill Questionnaire Present Pain Intensity score | Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score. | Patients will be asked in the office for their pain rating 5 minutes after injection | 
| Change in post-injection pain at 5 minutes using the Wong-Baker pain scale | Patients will be asked to report their pain on the Wong-Baker pain scale. | Patients will be asked in the office for their pain rating 5 minutes after injection | 
| Change in post-injection pain at 6 hours using the Short Form McGill Questionnaire Present Pain Intensity score. | Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score. | Patients will be called for their rating 6 hours after injection | 
| Change in post-injection pain at 6 hours using the Wong-Baker pain scale | Patients will be asked to report their pain on the Wong-Baker pain scale. | Patients will be called for their rating 6 hours after injection | 
| Change in post-injection pain at 24 hours using the Short Form McGill Questionnaire Present Pain Intensity score. | Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score. | Patients will be called for their rating 24 hours after injection | 
| Change in post-injection pain at 24 hours using the Wong-Baker pain scale | Patients will be asked to report their pain on the Wong-Baker pain scale. | Patients will be called for their rating 24 hours after injection |