Corneal Transplantation Clinical Trial
Official title:
Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01206127 -
DSAEK- Postoperative Positioning and Transplant Dislocation
|
N/A | |
Terminated |
NCT00764582 -
Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery
|
Phase 4 | |
Recruiting |
NCT05870566 -
Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
|
N/A | |
Recruiting |
NCT02084745 -
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
|
N/A | |
Unknown status |
NCT00834782 -
Comparison of DCT, ORA and GAT in Eyes After Penetrating Keratoplasty
|
Phase 4 | |
Withdrawn |
NCT00345020 -
Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
|
||
Completed |
NCT00000137 -
Collaborative Corneal Transplantation Studies (CCTS)
|
Phase 3 | |
Recruiting |
NCT04339907 -
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
|
N/A | |
Completed |
NCT00570648 -
A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization
|
N/A | |
Enrolling by invitation |
NCT03461978 -
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures
|
N/A | |
Not yet recruiting |
NCT05210478 -
Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea
|
||
Completed |
NCT01694914 -
Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
|
Phase 3 | |
Completed |
NCT03381794 -
The German Keratoplasty Registry of the German Ophthalmological Society (DOG)
|
N/A | |
Recruiting |
NCT03105466 -
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
|
N/A | |
Completed |
NCT00409656 -
Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
|
Phase 2 | |
Recruiting |
NCT01018888 -
Safety and Efficacy Study of Artificial Cornea
|
Phase 4 | |
Recruiting |
NCT04490902 -
Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty
|
N/A | |
Recruiting |
NCT04337944 -
Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis (KPro-HP-Endo)
|
N/A | |
Completed |
NCT01547975 -
Retrospective Analysis of Surgical Outcomes After Corneal Transplantation
|
N/A | |
Terminated |
NCT00447642 -
Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
|
Phase 3 |