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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cornea epithelial allograft | Experimental | Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD) |
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| Limbal conjunctival allograft | Active Comparator | Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal epithelial allograft | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of corneal surface in the recipient | Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient | 1 year |
| Restoration of corneal surface in the donor | Restoration of a completely epithelized, stable, and avascular corneal surface in the donor | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected and best-corrected visual acuity of recipients and donors | To assess changes of uncorrected and best-corrected visual acuity using ETDRS chart. | 1 year |
| Corneal power, astigmatism and aberration of recipients and donors |
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Inclusion Criteria:
Exclusion Criteria:
Recipients:
Donors:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| Limbal conjunctival allograft | Procedure | 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 laser | Device | A commercial femtosecond laser to create a particular shaped graft for transplantation |
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| Diamond knife | Device | A diamond knife to create a particular shaped limbal graft for transplantation |
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To measure changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
| 1 year |
| Corneal sensation of recipients and donors | To measure corneal sensation using Cochet-Bonnet esthesiometer. | 1 year |
| Corneal thickness of recipients and donors | 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 | To measure density of stromal nerve and stromal keratocytes using in vivo confocal microscopy | 1 year |
| Reconstruction of limbal palisades of Vogt of recipients | To assess reconstruction of limbal palisades of Vogt using in vivo confocal microscopy. | 1 year |
| Corneal graft rejection of recipients | To assess corneal graft rejection using slit-lamp microscopy. | 1 year |
| Corneal haze of recipients and donors | To assessing corneal haze using in vivo confocal microscopy | 1 year |