Clinical trial NCT01230593: Chalazion Conservative Treatment Trial
Official title: A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chalazion Unspecified Eye, Unspecified Eyelid
Chalazion Left Eye, Unspecified Eyelid
Chalazion Right Eye, Unspecified Eyelid
Chalazion Both Eyes
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Edward-Elmhurst Health System
First posted: 2010-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.


Eligibility criteria: Inclusion Criteria

* Patients age 18 and above
* Patient with a palpable chalazion on any eyelid
* Patients with multiple chalazia but only a single one on each lid
* Normal lid anatomy enabling lid eversion

Exclusion Criteria

* Patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy
* Patients allergic to any agents being used in the study (tobramycin, dexamethasone)
* Patients who have had previous eyelid surgery to the same eyelid as the chalazion
* Patients under 18 years of age
* Patients without palpable lid chalazion
* Patients with multiple chalazia on one eyelid
* Patients with concurrent eyelid infection (cellulitis or conjunctivitis)
* Patients unable to give consent

Primary outcomes:
measure: Number of Participants With Complete Resolution
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Chalazion Size Difference Post-Treatment
timeFrame: baseline and 4-6 weeks
Other outcomes:
Locations:
city: Elmhurst
country: United States
facility: Elmhurst Hospital Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Stoney Creek
country: Canada
facility: St. Joseph's Hospital Eye Clinic
state: Ontario
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Albert Y Wu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16.