Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04229771 |
| Other study ID # |
2019-216 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2020 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
December 2022 |
| Source |
William Beaumont Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: It is unknown whether instillation of a drop of anesthetic ophthalmic solution into
the eye such as proparacaine hydrochloride 0.5% prior to probing and irrigation of the tear
duct (lacrimal drainage) system improves participant comfort during the procedure. To date,
there have been no formal studies evaluating the possible benefit of this pretreatment.
Methods: Participants 18 years and older who present to the William Beaumont Hospital - Royal
Oak, Michigan outpatient ophthalmology clinic with a chief complaint of epiphora (excessive
tearing) who necessitate bilateral lower lid probing and irrigation of the lacrimal drainage
system will be enrolled in the study. One eye will be randomized to receive a drop of the
anesthetic Proparacaine hydrochloride 0.5% and the other eye will receive a control drop of
Balanced Salt Solution (BSS). Probing and irrigation will then be performed in the usual
fashion. The participant will then be questioned via survey on a pain scale of 1-5 as to the
amount of subjective pain experienced on each side during the procedure.
Expected Results: Investigators expect participants will experience statistically
significantly less pain in eyes that have received a drop of Proparacaine hydrochloride 0.5%
prior to performance of probing and irrigation compared to the eyes which have received the
control drop.
Description:
Rationale: It is common for male and female adults of all races with a chief complaint of
epiphora (excessive tearing) to express discomfort either verbally or through body language
while undergoing tear duct (canalicular) probing and irrigation even when no pathology is
detected. Use of a topical anesthetic during canalicular probing and irrigation is seen in
children but has yet to be formally investigated in adults to date. The goal of this study is
to identify whether or not instillation of a drop of Proparacaine hydrochloride 0.5%
ophthalmic solution into a participant's eye prior to performance of probing and irrigation
will improve participant comfort during the procedure and is therefore recommended.
Hypothesis: Administration of a drop of Proparacaine hydrochloride 0.5% ophthalmic solution
into the eye prior to probing and irrigation of the lower lid canalicular system will
decrease discomfort as compared to a control drop of BSS ophthalmic solution into the
opposite eye prior to the same procedure.
Null hypothesis: Administration of a drop of Proparacaine hydrochloride 0.5% ophthalmic
solution does not have an effect on discomfort during canalicular probing and irrigation.
Medication: Proparacaine hydrochloride ophthalmic solution, United States Pharmacopeia (USP)
0.5% is a local anesthetic drug intended for topical ophthalmic use. Proparacaine
Hydrochloride ophthalmic solution is a fast-acting anesthetic lasting 10-20 minutes.
Proparacaine hydrochloride ophthalmic solution, USP 0.5% is FDA approved for this indication.
Probing and irrigation: A common in-office ophthalmic procedure performed with a small gauge,
blunt tube on a syringe filled with BSS. The cannula is placed into the canaliculus (tear
duct) of one eyelid, and the BSS is used to irrigate the lacrimal system. This procedure
identifies whether or not obstruction of the lacrimal system is present. A participant with
an open (patent) system will taste the salty BSS solution in the nose. A participant with a
nasolacrimal duct obstruction (NLDO) or a more proximal canalicular obstruction will have
reflux of the irrigant out of the opposite lid (on the same side) canaliculus, the probed
canaliculus, or both and will usually not detect any irrigant within the nasopharynx.
Definitions:
Nasolacrimal drainage system: The physiologic apparatus which drains tears from the surface
of the eye into the nose (i.e. the tear drain). It consists of (from eye to nose) the punctum
(opening of the tube), the canaliculus (a thin tube within the eyelid), the lacrimal sac (a
sac that hold the tears that lies within the bone of the nose) and finally the nasolacrimal
duct (a duct that connects the lacrimal sac (-lacrimal) into the nose (naso-). A blockage
anywhere along this pathway can cause epiphora.
Epiphora: The pathological process of tears overflowing from the ocular surface and rolling
down the face. Commonly caused by obstructions of the lacrimal drainage system. Can cause
significant irritation and loss of vision.
