Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03105466
Status:
UNKNOWN
Last Update Posted:
2017-04-10
First Post:
2016-08-31
Brief Title:
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
Sponsor:
Zhongshan Ophthalmic Center Sun Yat-sen University
Organization:
Zhongshan Ophthalmic Center Sun Yat-sen University
Study Overview
Official Title:
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The performance of keratoplasty is hampered by the limited availability of donor cornea in many countries especially in Asia For this reason attempts have been made to fabricate artificial substitutes for natural human cornea So far all polymeric biomaterials such as collagen configurations and plastic compression could mimic the functional optically transparent but failed to replicate the complicate three-dimension microstructure of natural cornea Therefore despite some favorable results yielded by polymeric biomaterials they cannot be suited for long-term use To overcome these disadvantages in recent years porcine cornea appeared specifically attractive for xenotransplantation because of its accessibility and similarities to natural human cornea However xenotransplantation using fresh porcine cornea can occurs hyperacute immune rejection resulting in graft failure Such transplant rejection can be substantially lessened by using acellular porcine cornea APC which preserves the constructure of natural cornea whilst having well biocompatibility and low antigenicity These properties feature APC particularly suitable for high-risk keratoplasty such as corneal grafting in infectious keratitis
Use of APC in LK has been shown promise in many preclinical animal studies and initially in human clinic trail However to optimize APC biological and biomechanical properties the strategies for its preparation has evolved extensively over recent years like various decellularization approaches eg detergents enzymes human sera hypertonic solutions and et al and additional procedures eg collagen re-crosslinking and repeated frozen-dry Therefore in the current study the investigators analyzed the early surgical outcomes of deep anterior lamellar keratoplasty DALK using the APC that was very recently approved by the National Institutes for Food and Drug Control NIFDC of China for clinic practice for management of infective keratitis including fungal viral and acanthamoeba keratitis Here major concern of this study was to clarify the behavior of APC after implantation in participants
Use of APC in LK has been shown promise in many preclinical animal studies and initially in human clinic trail However to optimize APC biological and biomechanical properties the strategies for its preparation has evolved extensively over recent years like various decellularization approaches eg detergents enzymes human sera hypertonic solutions and et al and additional procedures eg collagen re-crosslinking and repeated frozen-dry Therefore in the current study the investigators analyzed the early surgical outcomes of deep anterior lamellar keratoplasty DALK using the APC that was very recently approved by the National Institutes for Food and Drug Control NIFDC of China for clinic practice for management of infective keratitis including fungal viral and acanthamoeba keratitis Here major concern of this study was to clarify the behavior of APC after implantation in participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None