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

Sponsor
Massachusetts Eye and Ear Infirmary (Other)
Overall Status
Recruiting
CT.gov ID
NCT05145959
Collaborator
(none)
30
1
27
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Maskin Probe
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts Eye and Ear Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts Eye and Ear Infirmary

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hajirah N. Saeed, M.D., Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT05145959
Other Study ID Numbers:
  • 2020P000608
First Posted:
Dec 6, 2021
Last Update Posted:
Dec 6, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Hajirah N. Saeed, M.D., Principal Investigator, Massachusetts Eye and Ear Infirmary
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2021