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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

Brief Summary:
This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.

Condition or disease Intervention/treatment Phase
Cicatrizing Conjunctivitis Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum Sjogren Syndrome Mucous Membrane Pemphigoid Chronic Graft Versus Host Disease Chemical Burn to Eye Procedure: minor salivary gland transplantation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Minor Salivary Gland Transplantation
Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839069


Contacts
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Contact: Hsiao-Sang Chu, MD, MS +886-2-23123456 ext 63804 stephaniechu@ntuh.gov.tw

Locations
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Taiwan
Department of Ophthalmology, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Hsiao Sang Chu, MD,MS    +886-2-23123456 ext 63804    stephaniechu@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Hsiao-Sang Chu, MD, MS Department of Ophthalmology, NTUH

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03839069     History of Changes
Other Study ID Numbers: 201503027DINB
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: for research purpose only
Additional relevant MeSH terms:
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Drug Eruptions
Drug Hypersensitivity
Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Sjogren's Syndrome
Stevens-Johnson Syndrome
Conjunctivitis
Pemphigoid, Benign Mucous Membrane
Pemphigoid, Bullous
Graft vs Host Disease
Syndrome
Burns, Chemical
Disease
Pathologic Processes
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Connective Tissue Diseases
Autoimmune Diseases