Recruiting

Meibomian Gland Probing

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT05145959

Conditions

Stevens-Johnson Syndrome

Toxic Epidermal Necrolyses

Ocular Surface Disease

Meibomitis

Meibomian Gland Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Maskin Probe

Study Details

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

Study ID

NCT05145959

Start date

Dec 1, 2021

Status verified date

Nov, 2021

Completion date

Mar 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Meibomian gland imaging (Meibography) - Qualitative description [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Catherine Liu, MD

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

Locations

Massachusetts Eye and Ear Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Catherine Liu, MD

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

Principal Investigator:

Hajirah Saeed, MD, MPH

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Dec 6, 2021

Last verified

Nov, 2021

Keywords

  • Stevens-Johnson Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2021-12-06.