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

NCT ID: NCT00543660

Last Updated: 2023-01-12

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2018-03-31

Brief Summary

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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

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Please see above.

Conditions

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Corneal Dystrophies, Hereditary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm DSEK

Intervention: DSEK

Group Type EXPERIMENTAL

Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Intervention Type PROCEDURE

Interventions

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Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Intervention Type PROCEDURE

Other Intervention Names

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Descemet Stripping Endothelial Keratoplasty (DSEK) Please see www.niios.com

Eligibility Criteria

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Inclusion Criteria

* Corneal endothelial disorders

Exclusion Criteria

* N/A
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amnitrans Eyebank Rotterdam

OTHER

Sponsor Role collaborator

Melles CorneaClinic Rotterdam

UNKNOWN

Sponsor Role collaborator

Netherlands Institute for Innovative Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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GRJ Melles, MD, PhD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerrit RJ Melles, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Netherlands Institute for Innovative Ocular Surgery

Locations

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Netherlands Institute for Innovative Ocular Surgery

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 17102659 (View on PubMed)

Other Identifiers

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NIIOS.1998.04

Identifier Type: -

Identifier Source: org_study_id

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