Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
Primary Purpose
Symblepharon, Dry Eye, Ocular Surface Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Salivary Gland and Labial Mucous Membrane Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Symblepharon focused on measuring Labial mucous membrane, symblepharon, dry eye, Stevens -Johnson syndrome, salivary gland, ocular surface disease, transplantation
Eligibility Criteria
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.
Sites / Locations
- UNIFESP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salivary Gland and Labial Mucous Membrane Transplantation
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01178242
First Posted
January 19, 2010
Last Updated
August 9, 2016
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01178242
Brief Title
Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symblepharon, Dry Eye, Ocular Surface Disease, Transplantation
Keywords
Labial mucous membrane, symblepharon, dry eye, Stevens -Johnson syndrome, salivary gland, ocular surface disease, transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salivary Gland and Labial Mucous Membrane Transplantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Salivary Gland and Labial Mucous Membrane Transplantation
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UNIFESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023062
Country
Brazil
12. IPD Sharing Statement
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Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
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