Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

April 7, 2017 updated by: Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Principal Investigator:
          • Jin Yuan, M.D., Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before surgery, 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the changes of visual contrast sensitivity
Time Frame: Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
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
1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
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
1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
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
1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
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)
Before surgery, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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