NCT00543660

Brief Summary

To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 1998

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

March 1, 1998

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

20 years

First QC Date

October 11, 2007

Last Update Submit

January 11, 2023

Conditions

Corneal Dystrophies, Hereditary

Keywords

Corneal transplantation, Descemet membrane, endothelium

Outcome Measures

Primary Outcomes (1)

  • Best spectacle corrected visual acuity

    1998 - 2018

Secondary Outcomes (1)

  • Corneal endothelial cell density

    1998-2018

Study Arms (1)

Intervention arm DSEK

EXPERIMENTAL

Intervention: DSEK

Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Interventions

Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)PROCEDURE
Also known as: Descemet Stripping Endothelial Keratoplasty (DSEK), Please see www.niios.com
Intervention arm DSEK

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Corneal endothelial disorders

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Institute for Innovative Ocular Surgery

Rotterdam, 3071 AA, Netherlands

Location

Related Publications (1)

  • Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.

    PMID: 17102659RESULT

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary

Interventions

Descemet Stripping Endothelial Keratoplasty

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsCorneal TransplantationRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Gerrit RJ Melles, MD PhD

    Netherlands Institute for Innovative Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 15, 2007

Study Start

March 1, 1998

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

NL(1)