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

This study has been completed.
Sponsor:
Information provided by:
Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01021046
First received: November 25, 2009
Last updated: August 2, 2010
Last verified: November 2006

November 25, 2009
August 2, 2010
December 2006
July 2010   (final data collection date for primary outcome measure)
rejection [ Designated as safety issue: Yes ]
rejection evaluation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01021046 on ClinicalTrials.gov Archive Site
laser scanning in vivo confocal microscopy [ Designated as safety issue: Yes ]
laser scanning in vivo confocal microscopy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Deep Anterior Lamellar Keratoplasty (DALK) Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
Deep Anterior Lamellar Keratoplasty Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glycerin Cryopreserved Acellular Corneal Tissue
  • Deep Anterior Lamellar Keratoplasty
  • High Risk Keratoplasty
  • Procedure: DALK using GCCT
    Deep anterior lamellar keratoplasty (DALK) using glycerin-cryopreserved corneal tissue
    Other Name: acellular tissue
  • Procedure: DALK using FCT
    Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue
  • Experimental: GCCT,corneal allograft survival ,DALK
    experimental group: deep anterior lamellar keratoplasty using glycerin-cryopreserved corneal tissue
    Intervention: Procedure: DALK using GCCT
  • Experimental: FCT,corneal allograft survival ,DALK
    control group: deep anterior lamellar keratoplasty using fresh corneal tissue
    Intervention: Procedure: DALK using FCT
Li J, Yu L, Deng Z, Wang L, Sun L, Ma H, Chen W. Deep anterior lamellar keratoplasty using acellular corneal tissue for prevention of allograft rejection in high-risk corneas. Am J Ophthalmol. 2011 Nov;152(5):762-70.e3. doi: 10.1016/j.ajo.2011.05.002. Epub 2011 Jul 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01021046
10001
Yes
Wei Chen, Eye Hospital, Wenzhou Medical College
Wenzhou Medical University
Not Provided
Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
Wenzhou Medical University
November 2006

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