Corneal Endothelium Delivery Instrument

Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00874835

Enrollment

100

Registered

2009-04-03

Start date

2009-03-31

Completion date

2010-10-31

Last updated

2010-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Transplantation

Keywords

Endothelial Keratoplasty, EK, Descemet Stripping Endothelial Keratoplasty, Corneal Transplantation, Keratoplasty, DSEK, DSAEK

Brief summary

The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.

Detailed description

Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterior chamber without compression, crushing, or squeezing the endothelial cells. The device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps). FDA has classified the device as Class I, Reserved.

Interventions

DEVICEEndoSaver™ Corneal Endothelium Delivery Instrument

Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.

Design outcomes

Primary

Measure	Time frame
6-month post-operative endothelial cell density	6-months post-operatively

Secondary

Measure	Time frame
12-month post-operative endothelial cell density	12-months post-operatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026