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

Wenzhou Medical University

Status: Completed

Conditions: Glycerin Cryopreserved Acellular Corneal Tissue; High Risk Keratoplasty; Deep Anterior Lamellar Keratoplasty

Treatments: Procedure: DALK using GCCT; Procedure: DALK using FCT

Study type: Interventional

Funder types: Other

Identifiers

NCT01021046

10001

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

GCCT,corneal allograft survival ,DALK

Experimental group

Description:

experimental group: deep anterior lamellar keratoplasty using glycerin-cryopreserved corneal tissue

Treatment:

Procedure: DALK using GCCT

FCT,corneal allograft survival ,DALK

Experimental group

Description:

control group: deep anterior lamellar keratoplasty using fresh corneal tissue

Treatment:

Procedure: DALK using FCT