Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

Not Applicable

• Conditions: Chemical Burn to Eye; Cicatrizing Conjunctivitis; Chronic Graft Versus Host Disease; Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum; Sjogren Syndrome; Mucous Membrane Pemphigoid
• Interventions: Procedure: minor salivary gland transplantation

• Registration Number: NCT03839069
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2016-08-31
• Study Start: 2016-09
• Status Verified: 2019-01
• Study First Submitted QC: 2019-02-10
• Last Update Submitted: 2019-02-10
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minor Salivary Gland Transplantation	minor salivary gland transplantation	Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Ophthalmology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan