Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

Chronic Graft Versus Host Disease Clinical Trial

Official title:

The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839069
• Other study ID #: 201503027DINB
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2021

Study information

• Verified date: January 2019
• Source: National Taiwan University Hospital
• Contact: Hsiao-Sang Chu, MD, MS
• Phone: +886-2-23123456
• Email: stephaniechu[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• minor 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.

Locations

Country	Name	City	State
Taiwan	Department of Ophthalmology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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