Salivary Gland Transplantation in the Treatment of 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Symblepharon Chemically-Induced Disorders Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Dry Eye Dry Eye Syndromes Erythema Erythema Multiforme Eye Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lacrimal Apparatus Diseases Mouth Diseases Ocular Surface Disease Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stevens-Johnson Syndrome Stomatitis Stomatognathic Diseases Transplantation

Age range

10 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNIFESP

São Paulo, 04023062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salivary Gland and Labial Mucous Membrane Transplantation

Procedure

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Aug 10, 2010
Registry last updated: Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed