Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

Corneal Transplantation Clinical Trial

Official title:

Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105466
• Other study ID #: 2016021
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2016
• Last updated: April 7, 2017
• Start date: February 2016
• Est. completion date: February 2020

Study information

• Verified date: April 2017
• Source: Zhongshan Ophthalmic Center, Sun Yet-san University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

Procedure:
• Deep anterior lamellar keratoplasty
Deep anterior lamellar keratoplasty using acellular porcine cornea; 0.05%Tacrolimus eye drops, four times a day for at least one year; 0.3% Tobradex eyedrops, four times-one times a day for one year.

Device:
• Acellular Porcine Cornea

Drug:
• Tacrolimus eye drops

• Tobradex eyedrops

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yet-san University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of Best corrected visual acuity		Before surgery, 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Secondary	the changes of visual contrast sensitivity		Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Secondary	the changes in the transparency of graft	using Slit lamp microscopic evaluation	1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Secondary	The changes in corneal thickness depth	using anterior segmental OCT	1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Secondary	The changes in corneal nerve regeneration	using Confocal microscopy	1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
Secondary	The changes of depression and anxiety status	Using Self-Rating Depression Scale (SDS) and Self-Rating Anxiaty Scale (SAS)	Before surgery, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery