NCT05663684 Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?
| NCT ID | NCT05663684 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Louisiana State University Health Sciences Center in New Orleans |
| Condition | Epiphora |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2020-06-30 |
| Primary Completion | 2022-12-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Louisiana State University or associated outpatient ophthalmology clinic(s) 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 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.
Eligibility Criteria
Inclusion Criteria: * Participants of any sex aged 18 years or older * Signs and symptoms of epiphora which necessitate performance of a diagnostic probing and irrigation of the bilateral lower eyelid lacrimal drainage system at Louisiana State University Health Sciences Center or any of the listed physician offices who present with a complaint of epiphora from either eye Exclusion Criteria: * A known allergy to topical proparacaine hydrochloride * Known pre-existing scarring, surgery, radiation to the nasolacrimal system * Presence of blockage and or reflux on probing and irrigation of either side * Cognitive Impairment