NCT01021046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 3, 2010

Status Verified

November 1, 2006

Enrollment Period

3.6 years

First QC Date

November 25, 2009

Last Update Submit

August 2, 2010

Conditions

Glycerin Cryopreserved Acellular Corneal TissueDeep Anterior Lamellar KeratoplastyHigh Risk Keratoplasty

Keywords

deep anterior lamellar keratoplastyrejectionhigh risk patientsacellular corneal tissue

Outcome Measures

Primary Outcomes (1)

  • rejection

Secondary Outcomes (1)

  • laser scanning in vivo confocal microscopy

Study Arms (2)

GCCT,corneal allograft survival ,DALK

EXPERIMENTAL

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

Procedure: DALK using GCCT

FCT,corneal allograft survival ,DALK

EXPERIMENTAL

control group: deep anterior lamellar keratoplasty using fresh corneal tissue

Procedure: DALK using FCT

Interventions

DALK using GCCTPROCEDURE

Deep anterior lamellar keratoplasty (DALK) using glycerin-cryopreserved corneal tissue

Also known as: acellular tissue
GCCT,corneal allograft survival ,DALK
DALK using FCTPROCEDURE

Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue

FCT,corneal allograft survival ,DALK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe bacterial keratitis
  • Herpes simplex keratitis
  • severe fungal keratitis
  • partial limbal deficiency after chemical burn

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (1)

  • Li J, Yu L, Deng Z, Wang L, Sun L, Ma H, Chen W. Deep anterior lamellar keratoplasty using acellular corneal tissue for prevention of allograft rejection in high-risk corneas. Am J Ophthalmol. 2011 Nov;152(5):762-70.e3. doi: 10.1016/j.ajo.2011.05.002. Epub 2011 Jul 30.

    PMID: 21803324DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Wei Chen, MD,PhD

    Eye Hospital, Wenzhou Medical College, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 26, 2009

Study Start

December 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 3, 2010

Record last verified: 2006-11

Locations

CN(1)