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

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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

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.
    



Study Type

Interventional


Primary Outcome

Meibomian gland imaging (Meibography) - Qualitative description

Secondary Outcome

 Ocular Surface Disease Index survey

Condition

Stevens-Johnson Syndrome

Intervention

Maskin Probe


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

December 1, 2021

Completion Date

March 1, 2024

Primary Completion Date

December 1, 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 617-523-7900, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05145959

Organization ID

2020P000608


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts Eye and Ear Infirmary


Study Sponsor

, , 


Verification Date

November 2021