Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

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

Detailed Description
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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.

Official Title
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The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

Conditions
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Cicatrizing Conjunctivitis, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, Sjogren Syndrome, Mucous Membrane Pemphigoid, Chronic Graft Versus Host Disease, Chemical Burn to Eye

Intervention / Treatment
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* Procedure: minor salivary gland transplantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minor Salivary Gland Transplantation<br>Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment. | Procedure: minor salivary gland transplantation<br>* The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 |