Corneal Endothelium Delivery Instrument

Ocular Systems, Inc.

Status and phase: Unknown; Phase 2

Conditions: Corneal Transplantation

Treatments: Device: EndoSaver™ Corneal Endothelium Delivery Instrument

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00874835

Endo33171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)