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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal epithelial autograft | Experimental | Femtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD |
|
| Limbal conjunctival autograft | Active Comparator | Diamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal epithelial autograft | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected and best-corrected visual acuity in both eyes | To measure changes of uncorrected and best-corrected visual acuity using ETDRS chart. | 1 year |
| Corneal power, astigmatism and aberration in both eyes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingfeng Zheng, M.D.Ph.D. | Contact | +8613922286455 | yingfeng.zheng@qq.com |
| 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 | Recruiting | Guanzhou | 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 autograft | Procedure | 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 laser | Device | A commercial femtosecond laser to create a particular shaped graft for transplantation |
|
| Diamond knife | Device | A diamond knife to create a particular shaped limbal graft for transplantation |
|
To changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
| 1 year |
| Corneal sensation in both eyes | To assess corneal sensation using Cochet-Bonnet esthesiometer. | 1 year |
| Corneal thickness in both eyes | To measure corneal thickness using anterior segment optical coherence tomography (AS-OCT). | 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. | 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. | 1 year |
| Corneal haze in both eyes | To measuring corneal haze using in vivo confocal microscopy. | 1 year |