Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

NCT ID: NCT03105466

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-02-29

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.

Conditions

Corneal Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acellular porcine cornea group

Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea

Group Type: EXPERIMENTAL

Deep anterior lamellar keratoplasty

Intervention Type: PROCEDURE

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.

Acellular Porcine Cornea

Intervention Type: DEVICE

Tacrolimus eye drops

Intervention Type: DRUG

Tobradex eyedrops

Intervention Type: DRUG

Interventions

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.

Intervention Type: PROCEDURE

Acellular Porcine Cornea

Intervention Type: DEVICE

Tacrolimus eye drops

Intervention Type: DRUG

Tobradex eyedrops

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Saiqun Li, M.D., Ph.D.

Role: primary

123213197@qq.com

86-013642710612

References

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.

Reference Type: DERIVED

PMID: 31900186 (View on PubMed)

Other Identifiers

2016021

Identifier Type: -

Identifier Source: org_study_id