Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Primary Purpose
Cicatrizing Conjunctivitis, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, Sjogren Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
minor salivary gland transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrizing Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- age 20-85 years old
- unilateral or bilateral cicatrizing conjunctivitis
- severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)
- chronic ocular surface disease score (COCS) over 3 points
- Oxford scheme over grade III
Exclusion Criteria:
- active ocular infection
- active corneal melting
- severe xerostomia (modified Schirmer I test result of less than 25mm)
Sites / Locations
- Department of Ophthalmology, National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Minor Salivary Gland Transplantation
Arm Description
Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.
Outcomes
Primary Outcome Measures
the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation
to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function.
the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation
to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.
the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.
Secondary Outcome Measures
the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation
to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface.
Full Information
NCT ID
NCT03839069
First Posted
August 31, 2016
Last Updated
February 10, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03839069
Brief Title
Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Official Title
The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.
Detailed Description
Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in combination with symblepharon and corneal opacity in these patients could lead to the poor visual and life quality, and less favorable prognosis of ocular reconstruction.
This study aims to prospectively evaluate the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear productivity (functional outcome) and the survival of graft (anatomical outcome) every three months. The investigators would also validate whether minor salivary gland transplantation is beneficial for the participant prior to further ocular reconstruction as limbal transplantation and corneal grafting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrizing Conjunctivitis, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, Sjogren Syndrome, Mucous Membrane Pemphigoid, Chronic Graft Versus Host Disease, Chemical Burn to Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minor Salivary Gland Transplantation
Arm Type
Experimental
Arm Description
Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.
Intervention Type
Procedure
Intervention Name(s)
minor salivary gland transplantation
Intervention Description
The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.
Primary Outcome Measure Information:
Title
the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation
Description
to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function.
Time Frame
the Schirmer's test will be performed every three months until 12 months after operation
Title
the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation
Description
to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.
Time Frame
the OSDI will be monitored every three months until 12 months
Title
the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
Description
to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.
Time Frame
the COCS will be monitored every three months until 12 months after operation
Secondary Outcome Measure Information:
Title
the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation
Description
to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface.
Time Frame
the impression cytology will be performed every three months until 12 months after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 20-85 years old
unilateral or bilateral cicatrizing conjunctivitis
severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)
chronic ocular surface disease score (COCS) over 3 points
Oxford scheme over grade III
Exclusion Criteria:
active ocular infection
active corneal melting
severe xerostomia (modified Schirmer I test result of less than 25mm)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Sang Chu, MD, MS
Phone
+886-2-23123456
Ext
63804
Email
stephaniechu@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Sang Chu, MD, MS
Organizational Affiliation
Department of Ophthalmology, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao Sang Chu, MD,MS
Phone
+886-2-23123456
Ext
63804
Email
stephaniechu@ntuh.gov.tw
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
for research purpose only
Learn more about this trial
Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
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