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

Mass Eye and Ear

Status: Unknown

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

Treatments: Device: Maskin Probe

Study type: Interventional

Funder types: Other

Identifiers

NCT05145959

2020P000608

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)