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

W

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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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