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

Not Applicable

Completed

• Conditions: Glycerin Cryopreserved Acellular Corneal Tissue; Deep Anterior Lamellar Keratoplasty; High Risk Keratoplasty
• Interventions: Procedure: DALK using GCCT; Procedure: DALK using FCT

• Registration Number: NCT01021046
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-11
• Study Start: 2006-12
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-08-02
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GCCT,corneal allograft survival ,DALK	DALK using GCCT	experimental group: deep anterior lamellar keratoplasty using glycerin-cryopreserved corneal tissue
FCT,corneal allograft survival ,DALK	DALK using FCT	control group: deep anterior lamellar keratoplasty using fresh corneal tissue

Primary Outcome Measures

Name	Time	Method
rejection

Secondary Outcome Measures

Name	Time	Method
laser scanning in vivo confocal microscopy

Trial Locations

Locations (1)

Eye Hospital, Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China