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Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

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ClinicalTrials.gov Identifier: NCT03839069
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2019)
  • the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation [ Time Frame: the Schirmer's test will be performed every three months until 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 [ Time Frame: the OSDI will be monitored every three months until 12 months ]
    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 [ Time Frame: the COCS will be monitored every three months until 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2019)
the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation [ Time Frame: the impression cytology will be performed every three months until 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Official Title  ICMJE The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cicatrizing Conjunctivitis
  • Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum
  • Sjogren Syndrome
  • Mucous Membrane Pemphigoid
  • Chronic Graft Versus Host Disease
  • Chemical Burn to Eye
Intervention  ICMJE Procedure: minor salivary gland transplantation
The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.
Study Arms  ICMJE Experimental: Minor Salivary Gland Transplantation
Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.
Intervention: Procedure: minor salivary gland transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hsiao-Sang Chu, MD, MS +886-2-23123456 ext 63804 stephaniechu@ntuh.gov.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03839069
Other Study ID Numbers  ICMJE 201503027DINB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: for research purpose only
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hsiao-Sang Chu, MD, MS Department of Ophthalmology, NTUH
PRS Account National Taiwan University Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP