NCT05145959

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Maskin Probe	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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2021-12-06
• Last updated: 2021-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study