The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Minor Salivary Gland Transplantation
Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.
Intervention: minor salivary gland transplantation (Procedure)
Outcomes
Primary Outcomes
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 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 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.
Secondary Outcomes
- 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)