Descemet Stripping (Automated) Endothelial Keratoplasty (... | NCT00543660

Studies
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

NCT00543660

Sponsor

Netherlands Institute for Innovative Ocular Surgery

Status

Completed

Last Update Posted

Jan 12, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Corneal Dystrophies, Hereditary

Interventions

Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1998

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Oct 11, 2007

First Submission Date that Met QC Criteria

Oct 11, 2007

First Posted Date

Oct 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2023

Last Update Posted Date

Jan 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GRJ Melles, MD, PhD, Director, Netherlands Institute for Innovative Ocular SurgeryPrincipal Investigator

Lead Sponsor

Netherlands Institute for Innovative Ocular SurgeryOTHER

Collaborators

Name	Class
Amnitrans Eyebank Rotterdam	OTHER
Melles CorneaClinic Rotterdam	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Please see above.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm DSEK	Experimental	Intervention: DSEK	Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)	Procedure		Intervention arm DSEK	Descemet Stripping Endothelial Keratoplasty (DSEK)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best spectacle corrected visual acuity		1998 - 2018

Secondary Outcomes

Measure	Description	Time Frame
Corneal endothelial cell density		1998-2018

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Corneal endothelial disorders

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerrit RJ Melles, MD PhD	Netherlands Institute for Innovative Ocular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Netherlands Institute for Innovative Ocular Surgery		Rotterdam		3071 AA	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17102659	Result	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.

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary
D030342	Genetic Diseases, Inborn

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics