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The purpose of this pilot study is to explore whether modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with severe corneal burn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified EA and AMLK | Experimental | Modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn. |
|
| LA and AMLK | Active Comparator | Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe corneal burn. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified EA and AMLK | Procedure | Two pieces of corneal epithelial tissue with 2mmx3mm will be obtained from the fellow eye using femtosecond laser technology. This epithelial autograft (EA) is then ready for transplantation on the disease eye, following the procedure of allogeneic middle lamellar keratoplasty (AMLK). |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of corneal reepithelialization in disease eyes | The success rate of patients with completely epithelized and avascular corneal surface in disease eyes | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingfeng Zheng | Contact | +8613922286455 | zhyfeng@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhognshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D005126 | Eye Burns |
| ID | Term |
|---|---|
| D005131 | Eye Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| LA and AMLK | Procedure | A 3-clock-hour limbal autograft (LA) will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following the procedure of AMLK. |
|
| D009422 |
| Nervous System Diseases |
| D002056 | Burns |
| D014947 | Wounds and Injuries |