Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Primary Purpose
Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses, Ocular Surface Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maskin Probe
Sponsored by
About this trial
This is an interventional treatment trial for Stevens-Johnson Syndrome focused on measuring Stevens-Johnson Syndrome
Eligibility Criteria
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
Sites / Locations
- Massachusetts Eye and Ear HospitalRecruiting
Outcomes
Primary Outcome Measures
Meibomian gland imaging (Meibography) - Qualitative description
To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05145959
First Posted
October 21, 2021
Last Updated
November 23, 2021
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT05145959
Brief Title
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Official Title
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses, Ocular Surface Disease, Meibomitis, Meibomian Gland Dysfunction, Dry Eye
Keywords
Stevens-Johnson Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Maskin Probe
Intervention Description
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 Information:
Title
Meibomian gland imaging (Meibography) - Qualitative description
Description
To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index survey
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Liu, MD
Phone
617-523-7900
Email
CLiu54@MEEI.Harvard.edu
Facility Information:
Facility Name
Massachusetts Eye and Ear Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Liu, MD
Phone
617-523-7900
Email
CLiu54@MEEI.Harvard.edu
First Name & Middle Initial & Last Name & Degree
Hajirah Saeed, MD, MPH
12. IPD Sharing Statement
Learn more about this trial
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
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