Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

NCT03105466 | Unknown

• 1 other identifier: 2016021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Corneal Transplantation; Xenotransplantation; Bioegineered cornea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• the changes of visual contrast sensitivity

  Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

• the changes in the transparency of graft

  1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

• The changes in corneal thickness depth

  1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

• The changes in corneal nerve regeneration

  1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

• The changes of depression and anxiety status

  Before surgery, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

Study Arms (1)

Acellular porcine cornea group

EXPERIMENTAL

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

Procedure: Deep anterior lamellar keratoplasty; Device: Acellular Porcine Cornea; Drug: Tacrolimus eye drops; Drug: Tobradex eyedrops

Interventions

Deep anterior lamellar keratoplasty 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 group

Acellular Porcine Cornea DEVICE

Acellular porcine cornea group

Tacrolimus eye drops DRUG

Acellular porcine cornea group

Tobradex eyedrops DRUG

Acellular porcine cornea group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• corneal diseases not involving the endothelial layer

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31900186 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: April 10, 2017
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

CN (1)