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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-11-15

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.

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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.

Conditions

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Pain Intravitreal Injection Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Patients will be masked. The assistant instilling the eyedrop will be masked to which eyedrop is used for each eye.

Study Groups

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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.

Group Type EXPERIMENTAL

Use of bromfenac 0.09% to reduce intravitreal injection pain

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Use of artificial tears to reduce intravitreal injection pain

Intervention Type DRUG

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

Interventions

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Use of bromfenac 0.09% to reduce intravitreal injection pain

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

Intervention Type DRUG

Use of artificial tears to reduce intravitreal injection pain

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes