Corneal Epithelial Autograft for LSCD
A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for the Treatment of Limbal Stem Cell Deficiency
1 other identifier
interventional
20
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedAugust 9, 2019
August 1, 2019
2.3 years
July 12, 2017
August 7, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Restoration of corneal surface in the diseased eye
Restoration of a completely epithelized, stable, and avascular corneal surface in the diseased eye.
1 year
Restoration of corneal surface in the fellow eye
Restoration of a completely epithelized, stable, and avascular corneal surface in the fellow eye.
1 year
Secondary Outcomes (7)
Uncorrected and best-corrected visual acuity in both eyes
1 year
Corneal power, astigmatism and aberration in both eyes
1 year
Corneal sensation in both eyes
1 year
Corneal thickness in both eyes
1 year
Density of stromal nerve and stromal keratocytes in both eyes
1 year
- +2 more secondary outcomes
Study Arms (2)
Corneal epithelial autograft
EXPERIMENTALFemtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD
Limbal conjunctival autograft
ACTIVE COMPARATORDiamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD
Interventions
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.
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.
A commercial femtosecond laser to create a particular shaped graft for transplantation
A diamond knife to create a particular shaped limbal graft for transplantation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chunxiao Wanglead
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guanzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yizhi Liu, M.D.Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
- PRINCIPAL INVESTIGATOR
Ting Huang, M.D.Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical investigator
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 14, 2017
Study Start
July 25, 2017
Primary Completion
October 30, 2019
Study Completion
December 30, 2019
Last Updated
August 9, 2019
Record last verified: 2019-08