Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis

NCT05145959 | Unknown FDA Device

• 1 other identifier: 2020P000608
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN. The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the treated and non-treated eyes before and after the intervention. Monitoring of outcomes will be measured by comparing the results of meibography at the initial visit and at the 6-month follow-up. The secondary outcome assessed will be patient symptoms. The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention. The investigators hypothesize that mechanical expression of meibomian glands within the first 6 months of SJS/TEN onset will significantly improve ocular surface disease and symptoms in those patients.

Conditions

Stevens-Johnson Syndrome; Toxic Epidermal Necrolyses; Ocular Surface Disease; Meibomitis; Meibomian Gland Dysfunction; Dry Eye

Keywords

Stevens-Johnson Syndrome

Outcome Measures

Primary Outcomes (1)

• Meibomian gland imaging (Meibography) - Qualitative description

  To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.

  6 months

Secondary Outcomes (1)

• Ocular Surface Disease Index survey

  6 months

Interventions

Maskin Probe DEVICE

The eyelids are examined using meibography to evaluate which eyelids are more severe (right or left). A drop of proparacaine 0.5% solution is added and a bandage contact lens is placed. To avoid patient discomfort, anesthetic ointment is instilled using a sterile cotton-tipped applicator. In some cases, 4% lidocaine can be directly applied to the lid margin. The Maskin probe will be passed through the gland orifice perpendicular to the lid margin. After first using a 1-mm probe, a 2- or 4-mm probes may be used in cases of persistent resistance. The BCL is removed and the eyes are rinsed with sterile preservative-free saline. The patient is given preservative-free artificial tears to use every hour. A brief slit lamp exam will performed in order to ensure that there is no unanticipated damage to the lid or cornea. The probing device will be properly disposed of in the sharps containers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with SJS/TEN presenting to the Massachusetts Eye and Ear Infirmary (MEEI) ophthalmology clinic or who were seen by the ophthalmology team acutely at the Massachusetts General Hospital (MGH).
• Patients must be in the Sub-acute phase of ocular SJS (within 6 months)
• Patients must have evidence of Meibomitis
• Patients must be adults (18 years of age or older)

You may not qualify if:

• Patients with unconfirmed diagnosis of SJS vs. Erythema multiforme (or other condition).
• Patients beyond the sub-acute phase of SJS
• Patients without evidence of Meibomitis (See above criteria)
• Patients under the age of 18

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Meibomitis; Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Blepharitis; Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Central Study Contacts

Catherine Liu, MD

CONTACT

617-523-7900; CLiu54@MEEI.Harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: December 6, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

US (1)