Clinical trial NCT03105466: Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
Official title: Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Transplantation
Keywords: Corneal Transplantation
Xenotransplantation
Bioegineered cornea
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (e.g. detergents, enzymes, human sera, hypertonic solutions and et al) and additional procedures (e.g. 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.


Eligibility criteria: Inclusion Criteria:

corneal diseases not involving the endothelial layer

Exclusion Criteria:

* corneal diseases involving the endothelial layer
* allergic to pig tissue
* do not accept xenotransplantation

Primary outcomes:
measure: the changes of Best corrected visual acuity
timeFrame: Before surgery, 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Secondary outcomes:
measure: the changes of visual contrast sensitivity
timeFrame: Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
measure: the changes in the transparency of graft
timeFrame: 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
measure: The changes in corneal thickness depth
timeFrame: 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
measure: The changes in corneal nerve regeneration
timeFrame: 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
measure: The changes of depression and anxiety status
timeFrame: Before surgery, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
citation: Li S, Li M, Gu L, Peng L, Deng Y, Zhong J, Wang B, Wang Q, Xiao Y, Yuan J. Risk factors influencing survival of acellular porcine corneal stroma in infectious keratitis: a prospective clinical study. J Transl Med. 2019 Dec 30;17(1):434. doi: 10.1186/s12967-019-02192-z.