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

January 19, 2010
August 9, 2010
December 2008
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01178242 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
Salivary Gland and Labial Mucous Membrane Transplantation in the Treatment of Severe Symblepharon and Dry Eye in Patients With Stevens-Johnson Syndrome.

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).

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Symblepharon
  • Dry Eye
  • Ocular Surface Disease
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
19
December 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
10 Years to 58 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01178242
0427/08
Yes
UNIFESP, Ethical Commite of UNIFESP
Federal University of São Paulo
Not Provided
Not Provided
Federal University of São Paulo
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP