Corneal Epithelial Allograft From Living-related Donor for LSCD

February 27, 2020 updated by: Chunxiao Wang

A Non-randomized Controlled Clinical Trial of Epithelial Allograft Transplantation From Living-related Donors for the Treatment of Limbal Stem Cell Deficiency

The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial allograft from living-related donor is more effective than limbal conjunctival allograft from living-related donor for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
  2. Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
  3. Having a human leukocyte antigen (HLA)-matched living-related donor (≥4/6 HLA-A/B/DR matched);
  4. Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria:

Recipients:

  1. LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement;
  2. LSCD by ocular surface disorders other than ocular burn;
  3. Eyelids malposition;
  4. The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
  5. High myopia with a spherical equivalent of -15.0 D or less;
  6. Corneal or ocular surface infection within 30 days prior to study entry;
  7. Ocular surface malignancy;
  8. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
  9. Renal failure with creatinine clearance< 25ml/min;
  10. Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
  11. Platelet levels < 150,000 or > 450,000 per microliter;
  12. Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
  13. Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
  14. Pregnancy (positive test) or lactation;
  15. Participation in another simultaneous medical investigation or clinical trial;
  16. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
  17. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
  18. Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
  19. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
  20. Signs of current infection, including fever and treatment with antibiotics;
  21. Active immunological diseases;
  22. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.

Donors:

  1. Cornea diseases (epithelial defects, neovascularization, etc.);
  2. Eyelids malposition;
  3. The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
  4. High myopia with a spherical equivalent of -15.0 D or less;
  5. Corneal or ocular surface infection within 30 days prior to study entry;
  6. Ocular surface malignancy;
  7. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
  8. Renal failure with creatinine clearance< 25ml/min;
  9. Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
  10. Platelet levels < 150,000 or > 450,000 per microliter;
  11. Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
  12. Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
  13. Pregnancy (positive test) or lactation;
  14. Participation in another simultaneous medical investigation or clinical trial;
  15. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
  16. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
  17. Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
  18. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
  19. Signs of current infection, including fever and treatment with antibiotics;
  20. Active immunological diseases;
  21. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cornea epithelial allograft
Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)
Procedure: Corneal epithelial allograft
A living-related donor's epithelial flap, equal in area to the recipient's diseased cornea bed, will be created using femtosecond laser technology. This corneal epithelial allograft is then ready for transplantation on the recipient's disease eye, following removal of the recipient's scarred and diseased epithelium.
Device: Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation
ACTIVE_COMPARATOR: Limbal conjunctival allograft
Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)
Procedure: Limbal conjunctival allograft
A 3- to 5- clock hour limbal-conjunctival allograft will be obtained from the living-related eye. This is then ready for transplantation on the recipient's disease eye following removal of the recipient's scarred and diseased epithelium.
Device: Diamond knife
A diamond knife to create a particular shaped limbal graft for transplantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Restoration of corneal surface in the recipient
Time Frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient
1 year
Restoration of corneal surface in the donor
Time Frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the donor
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Uncorrected and best-corrected visual acuity of recipients and donors
Time Frame: 1 year
To assess changes of uncorrected and best-corrected visual acuity using ETDRS chart.
1 year
Corneal power, astigmatism and aberration of recipients and donors
Time Frame: 1 year
To measure changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
1 year
Corneal sensation of recipients and donors
Time Frame: 1 year
To measure corneal sensation using Cochet-Bonnet esthesiometer.
1 year
Corneal thickness of recipients and donors
Time Frame: 1 year
To measure corneal thickness using Anterior Segment Optical Coherence Tomograph (AS-OCT).
1 year
Density of stromal nerve and stromal keratocytes of recipients and donors
Time Frame: 1 year
To measure density of stromal nerve and stromal keratocytes using in vivo confocal microscopy
1 year
Reconstruction of limbal palisades of Vogt of recipients
Time Frame: 1 year
To assess reconstruction of limbal palisades of Vogt using in vivo confocal microscopy.
1 year
Corneal graft rejection of recipients
Time Frame: 1 year
To assess corneal graft rejection using slit-lamp microscopy.
1 year
Corneal haze of recipients and donors
Time Frame: 1 year
To assessing corneal haze using in vivo confocal microscopy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chunxiao Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017KYPJ057

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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