Bupivacaine Epiphora Trial

McMaster University

Overview

The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Epiphora Ptosis

Interventions

0.75% bupivacaineDRUG

topical anesthetic

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Patients age 18 and above, patients with unilateral or bilateral excessive tearing. Exclusion Criteria: Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Change from Baseline Lacrimal Tear Lake at 6 months

Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye

Time frame: measurements at baseline and 6 months

Secondary Outcomes

Change from baseline Lid distraction at 6 months

distance (in mm) that the eyelids can be maximally pulled from the globe

Time frame: measurements at baseline and 6 months

Change from baseline Lid snap back at 6 months

Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers

Time frame: measurements at baseline and 6 months

Data from ClinicalTrials.gov

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