NCT01244776

Brief Summary

This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 6, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

November 18, 2010

Last Update Submit

May 5, 2011

Conditions

Corneal Ulcer

Outcome Measures

Primary Outcomes (1)

  • Rejection evaluation

    30 days following transplantation

Secondary Outcomes (1)

  • Corneal wound healing

    90 days following transplantation

Study Arms (1)

Acellular corneal matrix

EXPERIMENTAL
Device: acellular corneal matrix

Interventions

acellular corneal matrixDEVICE

Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.

Also known as: ACM
Acellular corneal matrix

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 75 yrs.
  • Corneal ulcer.
  • Informed consent.

You may not qualify if:

  • Corneal perforation.
  • Other ocular diseases.
  • The presence of systemic connective tissue diseases
  • Severe allergic constitution
  • Pregnancy
  • The presence of chronic disease, such as significant cardiovascular illness
  • The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
  • Any patient that is not suitable for recruitment, in the judgment of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Study Officials

  • Liuhe Zhou, M.D.

    Beijing Tongren Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongbo Lu

CONTACT

86-29-84776153yongerbo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

May 6, 2011

Record last verified: 2011-05

Locations

CN(1)