Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05663684
Status:
RECRUITING
Last Update Posted:
2022-12-23
First Post:
2022-12-15
Brief Title:
Does Topical Ophthalmic Proparacaine 05 Prior to Probing and Irrigation Decrease Pain
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Louisiana State University Health Sciences Center in New Orleans
Study Overview
Official Title:
Does Administration of Proparacaine Hydrochloride 05 Ophthalmic Solution Prior to Canalicular Probing and Irrigation Decrease Patient Discomfort
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose It is unknown whether instillation of a drop of anesthetic ophthalmic solution into the eye such as proparacaine hydrochloride 05 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 Louisiana State University or associated outpatient ophthalmology clinics with a 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 05 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 05 prior to performance of probing and irrigation compared to the eyes which have received the control drop
Methods Participants 18 years and older who present to the Louisiana State University or associated outpatient ophthalmology clinics with a 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 05 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 05 prior to performance of probing and irrigation compared to the eyes which have received the control drop
Detailed 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 05 ophthalmic solution into a participants 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 05 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 05 ophthalmic solution does not have an effect on discomfort during canalicular probing and irrigation
Medication Proparacaine hydrochloride ophthalmic solution United States Pharmacopeia USP 05 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 05 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 ie 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 visio
Hypothesis Administration of a drop of Proparacaine hydrochloride 05 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 05 ophthalmic solution does not have an effect on discomfort during canalicular probing and irrigation
Medication Proparacaine hydrochloride ophthalmic solution United States Pharmacopeia USP 05 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 05 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 ie 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 visio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None