Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

National Taiwan University

Status: Unknown

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

Treatments: Procedure: minor salivary gland transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03839069

201503027DINB

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Minor Salivary Gland Transplantation

Experimental group

Description:

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

Treatment:

Procedure: minor salivary gland transplantation