Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

February 10, 2019 updated by: National Taiwan University Hospital

The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • Department of Ophthalmology, National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Schirmer's test will be performed every three months until 12 months after operation
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 OSDI will be monitored every three months until 12 months
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.
the COCS will be monitored every three months until 12 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the impression cytology will be performed every three months until 12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hsiao-Sang Chu, MD, MS, Department of Ophthalmology, NTUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

February 10, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201503027DINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

for research purpose only

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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