Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

A Randomized, Observer-masked, Clinical Trial Comparing the Neusidl Corneal Inserter Corneal Transplant Technique to the Standard Forceps Insertion Technique for Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01357122

Enrollment

100

Registered

2011-05-20

Start date

2009-07-31

Completion date

2015-11-30

Last updated

2011-05-20

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

Conditions

Fuchs' Corneal Endothelial Dystrophy

Brief summary

This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current standard forceps insertion DSAEK technique. The goal of this study is to examine the damage to the corneal endothelium resulting from the use of the NCI device in comparison to the use of our standard surgical DSAEK technique over time.

Interventions

DEVICENCI Insertion

DSAEK surgery will be performed using the NCI to insert the donor tissue.

PROCEDUREStandard Forceps Insertion

DSAEK surgery will be performed using forceps to insert the donor tissue. This is our long-established technique for DSAEK, with well-documented excellent results.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 21 and over * A diagnosis of Fuchs' Corneal Endothelial Dystrophy

Exclusion criteria

* Under age 21 * Diagnosis of advanced glaucomatous disease * Diagnosis of significant retinal disease * Diagnosis of any other corneal dystrophy * Previous corneal transplant surgery * Previous glaucoma surgery * Previous retinal surgery * Previous refractive surgery

Design outcomes

Primary

Measure	Time frame	Description
Decrease in Endothelial Cell Density From Baseline Over Time	6, 12, 24, and 60 Months	Endothelial cell density (ECD) will be captured at each follow-up visit using a non-contact specular microscope. % Cell reduction from pre-operative baseline ECD will be calculated for each patient, and compared between treatment arms to evaluate each instrument's effect on long-term post-operative endothelial cell density.

Secondary

Measure	Time frame	Description
Adverse events	Any time during follow-up period (5 years)	Each patient will be monitored for incidence of graft dislocation, primary graft failure, immunologic graft rejection, and late endothelial failure. Rates will be compared between groups to ensure that the NCI does not increase the risk of these adverse events.

Countries

United States

Outcome results

None listed

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