Limbal Stem Cell DeficiencyNCT03217487
Corneal Epithelial Autograft for LSCD
A study testing Corneal epithelial autograft, Limbal conjunctival autograft 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 autograft is more effective than limbal conjunctival autograft 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 autograft, Limbal conjunctival autograft 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
- 25 Jul 2017to 30 Dec 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
- Unilateral 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;
- 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
- 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 pterygium;
- 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;
Show all 22Show fewer
- 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, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guanzhou, Guangdong, 510000
Yingfeng Zheng, M.D. Ph.D.
About this study
Official title: A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for the Treatment of Limbal Stem Cell Deficiency
The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- Corneal epithelial autograft, Limbal conjunctival autograft, 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 autograftProcedure or surgery
Epithelial tissue, equal in area to the diseased eye's cornea bed, will be obtained from the fellow eye using femtosecond laser technology. This corneal epithelial autograft is then ready for transplantation on the disease eye, following removal of scarred and diseased epithelium.
Limbal conjunctival autograftProcedure or surgery
A 3- to 5- clock hour limbal-conjunctival autograft will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following removal of 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 |
|---|---|---|
| Corneal epithelial autograft | Experimental | Femtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD Receives: Procedure: Corneal epithelial autograft; Device: Femtosecond laser |
| Limbal conjunctival autograft | Active comparator | Diamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD Receives: Procedure: Limbal conjunctival autograft; 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 diseased eye
Restoration of a completely epithelized, stable, and avascular corneal surface in the diseased eye.
Measured: 1 year
Restoration of corneal surface in the fellow eye
Restoration of a completely epithelized, stable, and avascular corneal surface in the fellow eye.
Measured: 1 year
Secondary outcomes (7)
Uncorrected and best-corrected visual acuity in both eyes
To measure changes of uncorrected and best-corrected visual acuity using ETDRS chart.
Measured: 1 year
Corneal power, astigmatism and aberration in both eyes
To changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
Measured: 1 year
Corneal sensation in both eyes
To assess corneal sensation using Cochet-Bonnet esthesiometer.
Measured: 1 year
Corneal thickness in both eyes
To measure corneal thickness using anterior segment optical coherence tomography (AS-OCT).
Measured: 1 year
Density of stromal nerve and stromal keratocytes in both eyes
To assessing density of stromal nerve and stromal keratocytes using in vivo confocal microscopy.
Measured: 1 year
Reconstruction of limbal palisades of Vogt in the diseased eye
To assessing reconstruction of limbal palisades of Vogt using in vivo confocal microscopy.
Measured: 1 year
Corneal haze in both eyes
To measuring 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 start25 Jul 2017
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT03217487
- Sponsor's protocol ID
- 2017KYPJ051
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2017
- Last updated
- 9 Aug 2019
- 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 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for the Treatment of Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT03217487
- Acronym / sponsor ID
- 2017KYPJ051
- Conditions
- Limbal Stem Cell Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chunxiao WangUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- 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 autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal epithelial autograft | Experimental | Procedure: Corneal epithelial autograft, Device: Femtosecond laserFemtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD |
| Limbal conjunctival autograft | Active comparator | Procedure: Limbal conjunctival autograft, Device: Diamond knifeDiamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral 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;
- 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 (22 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 pterygium;
- 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 autograftEpithelial tissue, equal in area to the diseased eye's cornea bed, will be obtained from the fellow eye using femtosecond laser technology. This corneal epithelial autograft is then ready for transplantation on the disease eye, following removal of scarred and diseased epithelium. | Procedure or surgery | Corneal epithelial autograft |
| Limbal conjunctival autograftA 3- to 5- clock hour limbal-conjunctival autograft will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following removal of scarred and diseased epithelium. | Procedure or surgery | Limbal conjunctival autograft |
| Femtosecond laserA commercial femtosecond laser to create a particular shaped graft for transplantation | Device | Corneal epithelial autograft |
| Diamond knifeA diamond knife to create a particular shaped limbal graft for transplantation | Device | Limbal conjunctival autograft |
Primary outcome
Restoration of corneal surface in the diseased eye
Time frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the diseased eye.
Restoration of corneal surface in the fellow eye
Time frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the fellow eye.
7 secondary outcomes
Uncorrected and best-corrected visual acuity in both eyes
Time frame: 1 year
Corneal power, astigmatism and aberration in both eyes
Time frame: 1 year
Corneal sensation in both eyes
Time frame: 1 year
Corneal thickness in both eyes
Time frame: 1 year
Density of stromal nerve and stromal keratocytes in both eyes
Time frame: 1 year
Reconstruction of limbal palisades of Vogt in the diseased eye
Time frame: 1 year
Corneal haze in both eyes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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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 autograft, Limbal conjunctival autograft 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 3 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingfeng Zheng, M.D.Ph.D. (+8613922286455, yingfeng.zheng@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of corneal surface in the diseased eye (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 9 Aug 2019.