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

August 2, 2010 updated by: Wenzhou Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Eye Hospital, Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rejection

Secondary Outcome Measures

Outcome Measure
laser scanning in vivo confocal microscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 26, 2009

Study Record Updates

Last Update Posted (Estimate)

August 3, 2010

Last Update Submitted That Met QC Criteria

August 2, 2010

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10001 (Disarm Therapeutics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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