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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • laser scanning in vivo confocal microscopy [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Wenzhou Medical University

Additional 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
Study First Received: November 25, 2009
Last Updated: August 2, 2010
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014