Chemical Burn to Eye, Chronic Graft Versus Host Disease, Cicatrizing Conjunctivitis, Mucous Membrane Pemphigoid, Sjogren Syndrome, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum
Conditions
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.
Interventions
PROCEDUREminor 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation | 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. |
Countries
Taiwan
Contacts
Primary ContactHsiao-Sang Chu, MD, MS
Outcome results
None listed