Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

NCT ID: NCT03839069

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Minor Salivary Gland Transplantation

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

Group Type EXPERIMENTAL

minor salivary gland transplantation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hsiao-Sang Chu, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, NTUH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hsiao-Sang Chu, MD, MS

Role: CONTACT

+886-2-23123456 ext. 63804

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hsiao Sang Chu, MD,MS

Role: primary

+886-2-23123456 ext. 63804

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201503027DINB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cornea Preservation Time Study
NCT01537393 COMPLETED PHASE4