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

Wills Eye

Status and phase: Completed; Phase 4

Conditions: Intravitreal Injection; Pain, Acute; Pain

Treatments: Drug: Use of artificial tears to reduce intravitreal injection pain; Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain

Study type: Interventional

Funder types: Other

Identifiers

NCT06130384

012475

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

97 participants in 2 patient groups, including a placebo group

Bromfenac 0.09%

Experimental group

Description:

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.

Treatment:

Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain

Artificial Tear

Placebo Comparator group

Description:

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.

Treatment:

Drug: Use of artificial tears to reduce intravitreal injection pain