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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

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date April 10, 2017
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
Official Title  ICMJE Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Corneal Transplantation
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Acellular porcine cornea group
Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea
Interventions:
  • Procedure: Deep anterior lamellar keratoplasty
  • Device: Acellular Porcine Cornea
  • Drug: Tacrolimus eye drops
  • Drug: Tobradex eyedrops
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03105466
Other Study ID Numbers  ICMJE 2016021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Sponsor  ICMJE Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhongshan Ophthalmic Center, Sun Yat-sen University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP