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NCT01178242 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
Salivary Gland and Labial Mucous Membrane Transplantation in the Treatment of Severe Symblepharon and Dry Eye in Patients With Stevens-Johnson Syndrome.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01178242
Other study ID # 0427/08
Secondary ID
Status Completed
Phase N/A
First received January 19, 2010
Last updated August 9, 2016
Start date December 2008
Est. completion date December 2010

Study information
Verified date August 2016
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date December 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 58 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil UNIFESP Sao Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 months Yes
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