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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac 0.09% | Experimental | 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. |
|
| Artificial Tear | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of bromfenac 0.09% to reduce intravitreal injection pain | Drug | The eyedrop (bromfenac) will be given to the assigned eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score | 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. | 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 Faces pain scale | 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. | 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 Pain Questionnaire Present Pain Intensity score. | 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. | Patients will be called for their rating 6 hours after injection |
| Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale | from 0 through 10, in which 10 is the worst pain level. | Patients will be called for their rating 6 hours after injection |
| Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score. | 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. | Patients will be called for their rating 24 hours after injection |
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Inclusion criteria are:
Exclusion criteria are:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States | ||
| Mid Atlantic Retina |
Only de-identified data will be shared amongst researchers.
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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.
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Patients will be masked. The assistant instilling the eyedrop will be masked to which eyedrop is used for each eye.
| Use of artificial tears to reduce intravitreal injection pain | Drug | The eyedrop (artificial tears) will be given to the assigned eye. |
|
| Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale |
from 0 through 10, in which 10 is the worst pain level. |
| Patients will be called for their rating 24 hours after injection |
| Bethlehem |
| Pennsylvania |
| 18017 |
| United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| University of Toronto | Toronto | Ontario | Canada |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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