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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01178242

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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	Phase
Symblepharon Dry Eye Ocular Surface Disease Transplantation	Procedure: Salivary Gland and Labial Mucous Membrane Transplantation	N/A

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

Actual Enrollment :

19 participants

Allocation:

N/A

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 :

Dec 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Dec 1, 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

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 58 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.