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

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ClinicalTrials.gov Identifier: NCT01178242
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Symblepharon Dry Eye Ocular Surface Disease Transplantation Procedure: Salivary Gland and Labial Mucous Membrane Transplantation

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2008
Primary Completion Date : April 2010
Study Completion Date : December 2010


Arms and Interventions

Arm Intervention/treatment
Experimental: Salivary Gland and Labial Mucous Membrane Transplantation 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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 58 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178242


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

Responsible Party: Ana Estela Besteti Pires Ponce Santa Anna, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01178242     History of Changes
Other Study ID Numbers: 0427/08
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by Ana Estela Besteti Pires Ponce Santa Anna, 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
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders