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

NCT ID: NCT01021046

Last Updated: 2010-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glycerin Cryopreserved Acellular Corneal Tissue Deep Anterior Lamellar Keratoplasty High Risk Keratoplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GCCT,corneal allograft survival ,DALK

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

Group Type EXPERIMENTAL

DALK using GCCT

Intervention Type PROCEDURE

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

FCT,corneal allograft survival ,DALK

control group: deep anterior lamellar keratoplasty using fresh corneal tissue

Group Type EXPERIMENTAL

DALK using FCT

Intervention Type PROCEDURE

Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DALK using GCCT

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

Intervention Type PROCEDURE

DALK using FCT

Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

acellular tissue

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eye Hospital, Wenzhou Medical College

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Eye Hospital, Wenzhou Medical College, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21803324 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cataract Refractive Suite Study
NCT02974140 TERMINATED NA
Corneal Tissue Inlay for Keratoconus
NCT02649738 ACTIVE_NOT_RECRUITING NA