Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04343222 |
| Other study ID # |
2019-0095 |
| Secondary ID |
A536000SMPH/OPHT |
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 27, 2019 |
| Est. completion date |
December 19, 2019 |
Study information
| Verified date |
September 2020 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Intravitreal injections (IVI) are a common form of treatment for multiple retinal
pathologies. The investigators hypothesize that an intervention with a topical NSAID will
alleviate pain experienced at intravitreal injection (IVI) and post-IVI. 46 participants will
be recruited, randomized into 1 of 3 treatment arms, and can expect to be on study for a day.
Description:
Intravitreal injections are a very common form of treatment for a variety of ocular
pathologies. The use of these injections has only increased given the large utility they
provide. They both improved visual outcomes and provided patients an overall better quality
of life. However, a problem experienced by patients who undergo these injections is the need
for multiple reoccurring injections to maintain control of their disease. It has long been an
issue to provide patients optimal pain relief both during and after their intravitreal
injections. Topical anesthesia is often utilized through frequent rounds of proparacaine eye
drops. Other providers often use Lidocaine gel or Lidocaine-soaked cotton swaps with variable
results in terms of pain control. Subconjunctival lidocaine has also been utilized with
variable control of pain, however patients did report anxiety with the thought of being given
an additional injection.
Patient pain is subjective and difficult to objectively quantify when comparing different
methods of post-injection control. One commonly employed pain rating system is the Wong-Baker
FACES pain scale which has been quite successful in objectively quantifying patient
discomfort. It should be noted that this scale is only reliable in a patient whom is able to
understand how the scale works.
Other research studies have shown adequate to improved pain control through the use of
topical non-steroidal anti-inflammatory drug (NSAID) eye drops. One study looked at the use
of topical Nepafenac 0.10% on post injection pain. This study used the McGill pain assessment
questionnaire, which not only quantified pain but the additional benefit of describing the
nature of the pain the patient experienced.
A clinical research study looked at pain immediately and 6 hours after injection. The
researchers found that when compared to the control group (artificial tears) the group who
received NSAID eye drops had better pain control. In a similar study, Bromfenac, another
topical NSAID eye drop, provided good pain relief post injection, setting a precedent for the
use of topical NSAIDs in controlling IVI pain.
However, studies have only reported pain relief immediately and 6 hours after injection.
There have not been any studies showing pain control 24 hours post injection. Furthermore, no
studies to date have compared the timing of application of a topical NSAID, in the
alleviation of long-term pain patients experience. Bromfenac 0.09% is the agent of choice
given its previously demonstrated effectiveness in pain control and also strength when
compared to other ophthalmic NSAIDs. This was demonstrated in a paper by Sheppard that
compared Bromfenac with other topical NSAID eye drops and proved that it offered
approximately 3-4 times higher levels of COX-2 inhibition. It has been approved by the FDA as
a one time daily eye drop to reduce inflammation. It is commonly utilized following cataract
surgery to help reduce intraocular inflammation. This study looks at this medication's
utility to control pain following IVI, another invasive procedure. Pain control would be
assessed immediately following injection, 6 hours post injection and 24 hours post injection.
This will allow evaluation of Bromfenac 0.09%'s effectiveness on overall immediate pain
control as well as on ocular discomfort/soreness that can often follow IVI. Additionally, two
intervention groups to compare Bromfenac 0.09% instillation 30 minutes prior to IVI and
instillation immediately following IVI.
The primary goal of this study is to determine if topically administered Bromfenac 0.09% eye
drops can reduce the discomfort that patient experience both during and after intravitreal
injections. Additionally, the effect of both pre and post injection application of topical
Bromfenac 0.09% on subjective pain scores will be investigated.
This study will be a pilot study consisting of 46 participants. These participants will be
selected from those that have a diagnosis requiring intravitreal injection of an anti-VEGF
agent (Vascular Endothelial Growth Factor (VEGF)). Participants that have already undergone
intravitreal injection at least once before will be eligible. This will serve to minimize
bias from initial injection anxiety and will give participants a comparative data point
(prior injection discomfort). Participants will be randomized into one of three groups, which
will be known as group A, B or C. The groups will have drop regimens as follows:
- Group A: Will receive 1 drop of topical Bromfenac 0.09% 30 minutes prior to the
injection and then 1 drop of an artificial tear eye drop immediately after the injection
and wash.
- Group B: Will receive 1 drop of an artificial tear eye drop 30 minutes prior to the
injection and then 1 drop of topical Bromfenac 0.09% immediately after the injection and
wash.
- Group C: Will receive 1 drop of an artificial tear eye drop 30 minutes prior to the
injection and then 1 drop of an artificial tear eye drop immediately after the injection
and wash.
All labels will be removed from the bottles and the participants will be blinded to which
group they belong to. The treating physicians will also be blinded to which group the
participants belong to.
Immediately following the injection, each participant will be asked to rate their pain using
the Wong-Baker FACES pain scale as well as the McGill Pain Questionnaire (SF-MPQ).
Participants will then be given instructions and will be told to expect a call at 6 and 24
hours regarding further follow up phone questionnaires. Participants will also be provided
with a phone number to contact should they have any complications (ie. discomfort, increased
pain, vision changes, or any other questions). Participants will be provided with a copy of
the Wong-Baker FACES pain scale and the McGill Pain Questionnaire to take home with them.
Participants will be called 6 hours post-injection for further assessment of their pain using
both the Wong-Baker FACES pain scale and the McGill Pain Questionnaire (SF-MPQ). At 24 hours,
participants will again be contacted and their pain will be assessed one final time using
both the Wong-Baker FACES pain scale and the McGill Pain Questionnaire (SF-MPQ). This will
serve as the last point of data gathered from participants.
