Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

NCT03839069 | Unknown

• 1 other identifier: 201503027DINB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cicatrizing Conjunctivitis; Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum; Sjogren Syndrome; Mucous Membrane Pemphigoid; Chronic Graft Versus Host Disease; Chemical Burn to Eye

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• 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

Study Arms (1)

Minor Salivary Gland Transplantation

EXPERIMENTAL

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

Procedure: minor salivary gland transplantation

Interventions

minor salivary gland transplantation PROCEDURE

The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.

Minor Salivary Gland Transplantation

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• active ocular infection
• active corneal melting
• severe xerostomia (modified Schirmer I test result of less than 25mm)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Sjogren's Syndrome; Pemphigoid, Benign Mucous Membrane; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Conjunctival Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Study Officials

• Hsiao-Sang Chu, MD, MS

  Department of Ophthalmology, NTUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao-Sang Chu, MD, MS

CONTACT

+886-2-23123456; stephaniechu@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: February 15, 2019
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)