Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2020

Interventions

  • 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
  • Drug: Tobradex eyedrops

Arms, Groups and Cohorts

  • Experimental: Acellular porcine cornea group
    • Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea

Clinical Trial Outcome Measures

Primary Measures

  • the changes of Best corrected visual acuity
    • Time Frame: Before surgery, 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

Secondary Measures

  • the changes of visual contrast sensitivity
    • Time Frame: Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
  • the changes in the transparency of graft
    • Time Frame: 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
    • using Slit lamp microscopic evaluation
  • The changes in corneal thickness depth
    • Time Frame: 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
    • using anterior segmental OCT
  • The changes in corneal nerve regeneration
    • Time Frame: 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
    • using Confocal microscopy
  • The changes of depression and anxiety status
    • Time Frame: Before surgery, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
    • Using Self-Rating Depression Scale (SDS) and Self-Rating Anxiaty Scale (SAS)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin Yuan, Professor – Zhongshan Ophthalmic Center, Sun Yat-sen University

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