Corneal Endothelium Delivery Instrument
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Ocular Systems, Inc..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Ocular Systems, Inc.
Collaborator:
Wake Forest University
Information provided by:
Ocular Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00874835
First received: April 1, 2009
Last updated: May 6, 2010
Last verified: May 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 1, 2009 | ||||
| Last Updated Date | May 6, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
6-month post-operative endothelial cell density [ Time Frame: 6-months post-operatively ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Post operative endothelial cell density [ Time Frame: 3-month and 6-month ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00874835 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
12-month post-operative endothelial cell density [ Time Frame: 12-months post-operatively ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Corneal Endothelium Delivery Instrument | ||||
| Official Title ICMJE | Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK) | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Corneal Transplantation | ||||
| Intervention ICMJE | Device: EndoSaver™ Corneal Endothelium Delivery Instrument
Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty. |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | October 2010 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 45 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00874835 | ||||
| Other Study ID Numbers ICMJE | Endo33171 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kurt R. Weber, Ocular Systems, Inc. | ||||
| Study Sponsor ICMJE | Ocular Systems, Inc. | ||||
| Collaborators ICMJE | Wake Forest University | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Ocular Systems, Inc. | ||||
| Verification Date | May 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||