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Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

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ClinicalTrials.gov Identifier: NCT03105466
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.


Condition or disease Intervention/treatment Phase
Corneal Transplantation Procedure: Deep anterior lamellar keratoplasty Device: Acellular Porcine Cornea Drug: Tacrolimus eye drops Drug: Tobradex eyedrops Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the changes of visual contrast sensitivity [ Time Frame: Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery ]
  2. 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

  3. 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

  4. 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

  5. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105466


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Saiqun Li, M.D., Ph.D.    86-013642710612    123213197@qq.com   
Principal Investigator: Jin Yuan, M.D., Ph.D.         
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Jin Yuan, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03105466     History of Changes
Other Study ID Numbers: 2016021
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Keywords provided by Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University:
Corneal Transplantation
Xenotransplantation
Bioegineered cornea
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases
Tobramycin, Dexamethasone Drug Combination
Ophthalmic Solutions
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists