Limbal Stem Cell DeficiencyNCT03217435
Corneal Epithelial Allograft From Living-related Donor for LSCD
A study testing Corneal epithelial allograft, Limbal conjunctival allograft and Femtosecond laser in people with Limbal Stem Cell Deficiency, run by Chunxiao Wang at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- Corneal epithelial allograft, Limbal conjunctival allograft and Femtosecond laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2017to 13 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
- Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
- Having a human leukocyte antigen (HLA)-matched living-related donor (≥4/6 HLA-A/B/DR matched);
- Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
Who cannot join
- Recipients:
- LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement;
- LSCD by ocular surface disorders other than ocular burn;
- Eyelids malposition;
- The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
- High myopia with a spherical equivalent of -15.0 D or less;
Show all 45Show fewer
- Corneal or ocular surface infection within 30 days prior to study entry;
- Ocular surface malignancy;
- Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
- Renal failure with creatinine clearance< 25ml/min;
- Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
- Platelet levels < 150,000 or > 450,000 per microliter;
- Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- 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;
- Pregnancy (positive test) or lactation;
- Participation in another simultaneous medical investigation or clinical trial;
- Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
- Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
- Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
- 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;
- Signs of current infection, including fever and treatment with antibiotics;
- Active immunological diseases;
- History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
- Donors:
- Cornea diseases (epithelial defects, neovascularization, etc.);
- Eyelids malposition;
- The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
- High myopia with a spherical equivalent of -15.0 D or less;
- Corneal or ocular surface infection within 30 days prior to study entry;
- Ocular surface malignancy;
- Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
- Renal failure with creatinine clearance< 25ml/min;
- Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
- Platelet levels < 150,000 or > 450,000 per microliter;
- Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- 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;
- Pregnancy (positive test) or lactation;
- Participation in another simultaneous medical investigation or clinical trial;
- Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
- Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
- Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
- 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;
- Signs of current infection, including fever and treatment with antibiotics;
- Active immunological diseases;
- History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510000
About this study
Official title: 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).
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- Corneal epithelial allograft, Limbal conjunctival allograft, Femtosecond laser, Diamond knife
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal epithelial allograftProcedure or surgery
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.
Limbal conjunctival allograftProcedure or surgery
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.
Femtosecond laserDevice
A commercial femtosecond laser to create a particular shaped graft for transplantation
Diamond knifeDevice
A diamond knife to create a particular shaped limbal graft for transplantation
| Study group | Role | What they receive |
|---|---|---|
| Cornea epithelial allograft | Experimental | Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD) Receives: Procedure: Corneal epithelial allograft; Device: Femtosecond laser |
| Limbal conjunctival allograft | Active comparator | Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD) Receives: Procedure: Limbal conjunctival allograft; Device: Diamond knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of corneal surface in the recipient
Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient
Measured: 1 year
Restoration of corneal surface in the donor
Restoration of a completely epithelized, stable, and avascular corneal surface in the donor
Measured: 1 year
Secondary outcomes (8)
Uncorrected and best-corrected visual acuity of recipients and donors
To assess changes of uncorrected and best-corrected visual acuity using ETDRS chart.
Measured: 1 year
Corneal power, astigmatism and aberration of recipients and donors
To measure changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
Measured: 1 year
Corneal sensation of recipients and donors
To measure corneal sensation using Cochet-Bonnet esthesiometer.
Measured: 1 year
Corneal thickness of recipients and donors
To measure corneal thickness using Anterior Segment Optical Coherence Tomograph (AS-OCT).
Measured: 1 year
Density of stromal nerve and stromal keratocytes of recipients and donors
To measure density of stromal nerve and stromal keratocytes using in vivo confocal microscopy
Measured: 1 year
Reconstruction of limbal palisades of Vogt of recipients
To assess reconstruction of limbal palisades of Vogt using in vivo confocal microscopy.
Measured: 1 year
Corneal graft rejection of recipients
To assess corneal graft rejection using slit-lamp microscopy.
Measured: 1 year
Corneal haze of recipients and donors
To assessing corneal haze using in vivo confocal microscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start27 Jul 2017
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem Cell DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chunxiao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunxiao Wang, Sun Yat-sen University
- Investigators
- Yizhi Liu, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityTing Huang, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217435
- Sponsor's protocol ID
- 2017KYPJ057
- Status last verified
- Feb 2020
- First submitted
- 12 Jul 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Controlled Clinical Trial of Epithelial Allograft Transplantation From Living-related Donors for the Treatment of Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT03217435
- Acronym / sponsor ID
- 2017KYPJ057
- Conditions
- Limbal Stem Cell Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chunxiao WangUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cornea epithelial allograft | Experimental | Procedure: Corneal epithelial allograft, Device: Femtosecond laserFemtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD) |
| Limbal conjunctival allograft | Active comparator | Procedure: Limbal conjunctival allograft, Device: Diamond knifeDiamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD) |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
- Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
- Having a human leukocyte antigen (HLA)-matched living-related donor (≥4/6 HLA-A/B/DR matched);
- Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
Key exclusion criteria (45 listed)
- LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement;
- LSCD by ocular surface disorders other than ocular burn;
- Eyelids malposition;
- The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
- High myopia with a spherical equivalent of -15.0 D or less;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal epithelial allograftA 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. | Procedure or surgery | Cornea epithelial allograft |
| Limbal conjunctival allograftA 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. | Procedure or surgery | Limbal conjunctival allograft |
| Femtosecond laserA commercial femtosecond laser to create a particular shaped graft for transplantation | Device | Cornea epithelial allograft |
| Diamond knifeA diamond knife to create a particular shaped limbal graft for transplantation | Device | Limbal conjunctival allograft |
Primary outcome
Restoration of corneal surface in the recipient
Time frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient
Restoration of corneal surface in the donor
Time frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the donor
8 secondary outcomes
Uncorrected and best-corrected visual acuity of recipients and donors
Time frame: 1 year
Corneal power, astigmatism and aberration of recipients and donors
Time frame: 1 year
Corneal sensation of recipients and donors
Time frame: 1 year
Corneal thickness of recipients and donors
Time frame: 1 year
Density of stromal nerve and stromal keratocytes of recipients and donors
Time frame: 1 year
Reconstruction of limbal palisades of Vogt of recipients
Time frame: 1 year
Corneal graft rejection of recipients
Time frame: 1 year
Corneal haze of recipients and donors
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yizhi Liu, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Ting Huang, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal epithelial allograft, Limbal conjunctival allograft and Femtosecond laser in people with Limbal Stem Cell Deficiency, run by Chunxiao Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of corneal surface in the recipient (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.