Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03839069

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cicatrizing Conjunctivitis Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum Sjogren Syndrome Mucous Membrane Pemphigoid Chronic Graft Versus Host Disease Chemical Burn to Eye	Procedure: minor salivary gland transplantation	N/A

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

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minor Salivary Gland Transplantation Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.	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.

Arm

Intervention/Treatment

Experimental: Minor Salivary Gland Transplantation

Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.