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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145959
• Other study ID #: 2020P000608
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2021
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Catherine Liu, MD
• Phone: 617-523-7900
• Email: CLiu54[@]MEEI.Harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ocular Surface Disease Index survey	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.	6 months