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Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01178242
First received: January 19, 2010
Last updated: August 9, 2010
Last verified: December 2008
History of Changes
  Purpose

The purpose of this study is to evaluate salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson Syndrome (SJS).


Condition Intervention
Symblepharon
Dry Eye
Ocular Surface Disease
Transplantation
 Procedure: Salivary Gland and Labial Mucous Membrane Transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salivary Gland and Labial Mucous Membrane Transplantation in the Treatment of Severe Symblepharon and Dry Eye in Patients With Stevens-Johnson Syndrome.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • A Complete ophthalmic exam including Schirmer I test , slit lamp exam, fundoscopy will be perform before and six months after surgery. Symptons improvement considered positive if patients will refer improvement of eye moisturasing and motility. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 19
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Salivary Gland and Labial Mucous Membrane Transplantation
    Minor salivary glands (SG) will be obtain "en block" from the same donor site, at the inferior or superior labial mucous membrane, above the orbicularis oris muscle to correct lubrication. The thin split thickness graft of mucous membrane will be suture to the sclera with absorbable sutures
Detailed Description:

This study was performed to evaluate the use of salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to SJS. Labial mucous membrane and salivary gland transplantation showed to be a good option in the treatment of severe symblepharon and dry eye secondary to SJS. labial mucous membrane, salivary glands, symblepharon, entropion, transplantation, graft.

  Eligibility

Ages Eligible for Study:   10 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only patients with poor visual acuity, less or equal to 20/200, and Schirmer I test equal to zero.
  • Eyes with symblepharon or ankyloblepharon that did not allow the placement of a Schirmer test strip will be consider not measurable.

Exclusion Criteria:

  • Active infection and corneal melting or perforation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178242

Locations
Brazil
UNIFESP
Sao Paulo, SP, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

Responsible Party: UNIFESP, Ethical Commite of UNIFESP
ClinicalTrials.gov Identifier: NCT01178242     History of Changes
Other Study ID Numbers: 0427/08
Study First Received: January 19, 2010
Last Updated: August 9, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Labial mucous membrane
symblepharon
dry eye
Stevens -Johnson syndrome
 salivary gland
ocular surface disease
transplantation

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Stevens-Johnson Syndrome
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
 Lacrimal Apparatus Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Erythema Multiforme
Erythema
Skin Diseases
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on May 16, 2013