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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minor Salivary Gland Transplantation | Experimental | Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minor salivary gland transplantation | Procedure | The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsiao-Sang Chu, MD, MS | Contact | +886-2-23123456 | 63804 | stephaniechu@ntuh.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hsiao-Sang Chu, MD, MS | Department of Ophthalmology, NTUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
for research purpose only
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| D012859 | Sjogren's Syndrome |
| D010390 | Pemphigoid, Benign Mucous Membrane |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D003229 | Conjunctival Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
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