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

Wills Eye97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain Intravitreal Injection Pain, Acute

Interventions

Use of bromfenac 0.09% to reduce intravitreal injection painDRUG

The eyedrop (bromfenac) will be given to the assigned eye.

Use of artificial tears to reduce intravitreal injection painDRUG

The eyedrop (artificial tears) will be given to the assigned eye.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Mid Atlantic Retina

Bethlehem, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Retina Consultants of San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Patients will be called for their rating 24 hours after injection

Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale

Data from ClinicalTrials.gov

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