Modified Corneal EA With Middle LKP for Severe Corneal Burn
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|ClinicalTrials.gov Identifier: NCT03498846|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Corneal Burn||Procedure: Modified EA and AMLK Procedure: LA and AMLK||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modified Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Corneal Burn|
|Actual Study Start Date :||May 10, 2018|
|Estimated Primary Completion Date :||December 9, 2019|
|Estimated Study Completion Date :||May 9, 2020|
Experimental: Modified EA and AMLK
Modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn.
Procedure: Modified EA and AMLK
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).
Active Comparator: LA and AMLK
Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe corneal burn.
Procedure: LA and AMLK
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.
- Success rate of corneal reepithelialization in disease eyes [ Time Frame: 12 months ]The success rate of patients with completely epithelized and avascular corneal surface in disease eyes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498846
|Contact: Yingfeng Zhengfirstname.lastname@example.org|
|Zhognshan Ophthalmic Center, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Yizhi Liu|