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

NCT ID: NCT01178242

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Symblepharon Dry Eye Ocular Surface Disease Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salivary Gland and Labial Mucous Membrane Transplantation

Group Type EXPERIMENTAL

Salivary Gland and Labial Mucous Membrane Transplantation

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ana Estela Besteti Pires Ponce Santa Anna

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UNIFESP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0427/08

Identifier Type: -

Identifier Source: org_study_id

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