Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Bromfenac 0.09% 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
The eyedrop (bromfenac) will be given to the assigned eye.
|
Placebo Comparator: Artificial Tear 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
The eyedrop (artificial tears) will be given to the assigned eye.
|
Outcome Measures
Primary Outcome Measures
- Change in post-injection pain at 5 minutes using the Short Form McGill 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.
- Change in post-injection pain at 5 minutes using the Wong-Baker 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 pain scale.
- Change in post-injection pain at 6 hours using the Short Form McGill 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.
- Change in post-injection pain at 6 hours using the Wong-Baker pain scale [Patients will be called for their rating 6 hours after injection]
Patients will be asked to report their pain on the Wong-Baker pain scale.
- Change in post-injection pain at 24 hours using the Short Form McGill 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 Questionnaire Present Pain Intensity score.
- Change in post-injection pain at 24 hours using the Wong-Baker pain scale [Patients will be called for their rating 24 hours after injection]
Patients will be asked to report their pain on the Wong-Baker pain scale.
Eligibility Criteria
Criteria
Inclusion criteria are:
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Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
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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.
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Age greater than 18
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Patient's that have had at least three prior injections in each eye
Exclusion criteria are:
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Prior ocular surgery (non-cataract)
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Herpetic eye disease
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Uncontrolled uveitis
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Active conjunctivitis, keratitis or keratopathy
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Current unilateral use of prescription eye drops.
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Allergy to NSAID
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ophthalmic Consultants of Boston | Boston | Massachusetts | United States | 02114 |
2 | Mid Atlantic Retina | Bethlehem | Pennsylvania | United States | 18017 |
3 | Mid Atlantic Retina | Philadelphia | Pennsylvania | United States | 19107 |
4 | Retina Consultants of San Antonio | San Antonio | Texas | United States | 78240 |
5 | University of Toronto | Toronto | Ontario | Canada |
Sponsors and Collaborators
- Wills Eye
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 012475