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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021046
First Posted: November 26, 2009
Last Update Posted: August 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wenzhou Medical University
  Purpose
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 Intervention
Glycerin Cryopreserved Acellular Corneal Tissue Deep Anterior Lamellar Keratoplasty High Risk Keratoplasty Procedure: DALK using GCCT Procedure: DALK using FCT

Study Type: Interventional
Study Design: 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

Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • rejection

Secondary Outcome Measures:
  • laser scanning in vivo confocal microscopy

Estimated Enrollment: 78
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT01021046


Locations
China, Zhejiang
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei Chen, Eye Hospital, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01021046     History of Changes
Other Study ID Numbers: 10001
First Submitted: November 25, 2009
First Posted: November 26, 2009
Last Update Posted: August 3, 2010
Last Verified: November 2006

Keywords provided by Wenzhou Medical University:
deep anterior lamellar keratoplasty
rejection
high risk patients
acellular corneal tissue