Clinical trial NCT03839069: Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Official title: The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrizing Conjunctivitis
Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum
Sjogren Syndrome
Mucous Membrane Pemphigoid
Chronic Graft Versus Host Disease
Chemical Burn to Eye
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation
timeFrame: the Schirmer's test will be performed every three months until 12 months after operation
measure: the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation
timeFrame: the OSDI will be monitored every three months until 12 months
measure: the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
timeFrame: the COCS will be monitored every three months until 12 months after operation
Secondary outcomes:
measure: the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation
timeFrame: the impression cytology will be performed every three months until 12 months after operation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital
Study officials:
affiliation: Department of Ophthalmology, NTUH
name: Hsiao-Sang Chu, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: