Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
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|ClinicalTrials.gov Identifier: NCT03839069|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
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.
- 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.
- 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 conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839069
|Contact: Hsiao-Sang Chu, MD, MS||+886-2-23123456 ext firstname.lastname@example.org|
|Department of Ophthalmology, National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10002|
|Contact: Hsiao Sang Chu, MD,MS +886-2-23123456 ext 63804 email@example.com|
|Principal Investigator:||Hsiao-Sang Chu, MD, MS||Department of Ophthalmology, NTUH|