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Deep Anterior Lamellar Keratoplasty (DALK) Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients

Sponsor
Wenzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT01021046
Collaborator
(none)
78
Enrollment
1
Location
2
Arms
43
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK) using acellular tissue will promote corneal graft survival in high risk patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: DALK using GCCT
  • Procedure: DALK using FCT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Deep Anterior Lamellar Keratoplasty Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: GCCT,corneal allograft survival ,DALK

experimental group: deep anterior lamellar keratoplasty using glycerin-cryopreserved corneal tissue

Procedure: DALK using GCCT
Deep anterior lamellar keratoplasty (DALK) using glycerin-cryopreserved corneal tissue
Other Names:
  • acellular tissue

    		•
    Experimental: FCT,corneal allograft survival ,DALK

    control group: deep anterior lamellar keratoplasty using fresh corneal tissue

    Procedure: DALK using FCT
    Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue

    Outcome Measures

    Primary Outcome Measures

    1. rejection []

    Secondary Outcome Measures

    1. laser scanning in vivo confocal microscopy []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • severe bacterial keratitis

    • Herpes simplex keratitis

    • severe fungal keratitis

    • partial limbal deficiency after chemical burn

    Exclusion Criteria:

    • posterior stroma involved in severe bacterial and fungal keratitis

    • dry eye

    • glaucoma or intraocular pressure greater than 21 mmHg

    • amblyopia

    • retinal abnormalities

    • patients with severe systemic diseases not good for ocular surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hospital, Wenzhou Medical College Wenzhou Zhejiang China 325027

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    • Principal Investigator: Wei Chen, MD,PhD, Eye Hospital, Wenzhou Medical College, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01021046
    Other Study ID Numbers:
    • 10001
    First Posted:
    Nov 26, 2009
    Last Update Posted:
    Aug 3, 2010
    Last Verified:
    Nov 1, 2006
    Keywords provided by , ,
    deep anterior lamellar keratoplasty
    rejection
    high risk patients
    acellular corneal tissue

    Study Results

    No Results Posted as of Aug 3, 2010