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

Not Applicable

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

• Registration Number: NCT05145959
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study Start: 2021-12-01
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Meibomian gland imaging (Meibography) - Qualitative description	6 months	To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index survey	6 months	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.

Trial Locations

Locations (1)

Massachusetts Eye and Ear Hospital; 🇺🇸 Boston, Massachusetts, United States