Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
Salivary Gland and Labial Mucous Membrane Transplantation in the Treatment of Severe Symblepharon and Dry Eye in Patients With Stevens-Johnson Syndrome.
1 other identifier
interventional
19
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 11, 2016
August 1, 2016
1.3 years
January 19, 2010
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Salivary Gland and Labial Mucous Membrane Transplantation
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Active infection and corneal melting or perforation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNIFESP
São Paulo, São Paulo, 04023062, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 19, 2010
First Posted
August 10, 2010
Study Start
December 1, 2008
Primary Completion
April 1, 2010
Study Completion
December 1, 2010
Last Updated
August 11, 2016
Record last verified: 2016-08