Skip to main content
OpenTrials
Completed

NCT Number: NCT06130384

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Acute Pain Intravitreal Injection Neurologic Manifestations Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Toronto, Toronto, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of bromfenac 0.09% to reduce intravitreal injection pain

Drug

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

Use of artificial tears to reduce intravitreal injection pain

Drug

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

Primary outcomes

  1. Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score

    Time frame: 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, ranging from 0 to 5, in which 5 is the worst pain level.

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

    Time frame: 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 Faces pain scale, ranging from 0 through 10, in which 10 is the worst pain level.

  3. Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.

    Time frame: 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, ranging from 0 to 5, in which 5 is the worst pain level.

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

    Time frame: Patients will be called for their rating 6 hours after injection

    from 0 through 10, in which 10 is the worst pain level.

  5. Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.

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

    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.

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

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

    from 0 through 10, in which 10 is the worst pain level.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.