Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
Study NCT ID:
NCT05145959
Status:
UNKNOWN
Last Update Posted:
2021-12-06
First Post:
2021-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Sponsor:
Massachusetts Eye and Ear Infirmary
Organization:
Study Overview
Official Title:
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: