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

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ClinicalTrials.gov Identifier: NCT01021046
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Wenzhou Medical University

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
Glycerin Cryopreserved Acellular Corneal Tissue Deep Anterior Lamellar Keratoplasty High Risk Keratoplasty Procedure: DALK using GCCT Procedure: DALK using FCT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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 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




Primary Outcome Measures :
  1. rejection

Secondary Outcome Measures :
  1. laser scanning in vivo confocal microscopy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: November 26, 2009    Key Record Dates
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