Clinical trials: Endothelial Keratoplasty
Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).
- Conditions
- Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible)
- Trial name
- TE-EK (NCT04319848)
- Testing
- TE-EK treatment group
- Where
- Singapore
- Volunteers
- 30 people
- Sponsor
- Singapore Eye Research Institute
Keratoconus
PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus
Rationale: Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive properties of the cornea result in loss of visual acuity.
- Trial name
- PENTACON (NCT01145937)
- Testing
- PET, DALK
- Where
- 5 sites in Netherlands
- Volunteers
- 14 people
- Sponsor
- UMC Utrecht
Endothelial Cell Loss With Different Insertion Devices
Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide.
- Trial name
- NCT01284543
- Testing
- Use of the Tan EndoGlide to insert donor graft, Busin Glide for delivery of the donor graft
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- University Health Network, Toronto
Fuchs' Endothelial Dystrophy
Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea
This study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the cornea in patients with Fuchs' endothelial corneal dystrophy (FECD).
- Trial name
- EDEMAS (NCT04140422)
- Testing
- Hyperosmolar eye drops
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- University Eye Hospital, Freiburg
Corneal Endothelial Decompensation, Fuchs' Endothelial Dystrophy
Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss
This double-masked multi-center trial will evaluate the association of diabetes in the cornea donor with transplant success and loss of endothelial cells through 1 year following Descemet membrane endothelial keratoplasty (DMEK).
- Trial name
- DEKS (NCT05134480)
- Testing
- Descemet membrane endothelial keratoplasty
- Where
- 2 sites in United States
- Volunteers
- 1,097 people
- Sponsor
- Case Western Reserve University
Endothelial Dystrophy, Secondary Bullous Keratopathy
Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation
After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection. However, the optimal postoperative treatment regimen is unknown.
- Conditions
- Endothelial Dystrophy, Secondary Bullous Keratopathy, Posterior Lamellar Keratoplasty, Descemet's Stripping Endothelial Keratoplasty
- Trial name
- NCT01682421
- Testing
- Weak steroid (Flurolon, Allergan), Potent steroid (Maxidex, Alcon)
- Where
- Denmark
- Sponsor
- Aarhus University Hospital
Bullous Keratopathy
The SNEC DSAEK EndoGlide Clinical Trial
The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide as a donor insertion device in DSAEK surgery.
- Trial name
- NCT01122043
- Testing
- Endoglide
- Where
- Singapore
- Volunteers
- 100 people
- Sponsor
- Singapore Eye Research Institute
Fuchs Endothelial Corneal Dystrophy, Descemet Membrane Endothelial Keratoplasty (DMEK)
Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)
The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye.
- Trial name
- SUPINE (NCT07373821)
- Testing
- Duration of Supine Positioning
- Where
- Germany
- Volunteers
- 102 people
- Sponsor
- University Hospital Heidelberg
Fuchs Dystrophy, Corneal Edema
A Comparison Between Full Thickness and Partial Thickness Corneal Transplantation for Corneal Edema
The objectives of this study are to compare the visual and refractive outcomes of deep lamellar endothelial keratoplasty (DLEK) with penetrating keratoplasty as treatment for certain cases of corneal edema due to endothelial…
- Trial name
- NCT00346138
- Testing
- Corneal transplantation
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Mayo Clinic
Corneal Disease, Fuch's Dystrophy
Cornea Donor Study
The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following objectives: To determine whether the graft-failure rate over a 5-year follow-up period following corneal transplantation is the same when…
- Conditions
- Corneal Disease, Fuch's Dystrophy, Pseudophakic Corneal Edema
- Trial name
- CDS (NCT00006411)
- Testing
- corneas assigned by donor age group
- Where
- United States
- Volunteers
- 1,090 people
- Sponsor
- National Eye Institute (NEI)
Fuchs' Endothelial Dystrophy, Bullous Keratopathy
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
- Trial name
- NCT03407755
- Testing
- Intraocular gas
- Where
- Denmark
- Volunteers
- 104 people
- Sponsor
- Glostrup University Hospital, Copenhagen
Corneal Transplant Failure, Corneal Endothelial Cell Loss
The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the…
- Trial name
- V-CHECK (NCT05847387)
- Testing
- V-Check
- Where
- 12 sites in Belgium, Germany and 4 more
- Volunteers
- 135 people
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Fuchs Endothelial Dystrophy
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal…
- Trial name
- NCT03813056
- Testing
- Glanatec, Optive, Ophthalmic Solution, Descemet Membrane Endothelial Keratoplasty
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Michael D. Straiko, MD
Fuchs Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years
This multi-center clinical trial is designed to assess the association of diabetes in a cornea donor with transplant success and loss of endothelial cells 5 years following Descemet membrane endothelial keratoplasty (DMEK).
- Trial name
- DEKS (NCT07217249)
- Testing
- Descemet membrane endothelial keratoplasty
- Where
- 14 sites in United States
- Volunteers
- 570 people
- Sponsor
- Case Western Reserve University
Fuch's Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media
The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium…
- Trial name
- SFM (NCT00623584)
- Testing
- Corneal transplantation
- Where
- 2 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Klinikum Chemnitz gGmbH
Corneal Diseases
Functional Antigen Matching in Corneal Transplantation
Penetrating keratoplasty is one of the most commonly performed transplantation surgeries. Graft rejection is a major complication.
- Trial name
- FANCY (NCT00810472)
- Testing
- HLA Matching, Penetrating keratoplasty
- Where
- Germany
- Volunteers
- 650 people
- Sponsor
- University Hospital Freiburg
Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
The Effect Of Preoperative Parameters On Success After DMEK Surgery
The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.
- Conditions
- Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Descemet's Membrane; Defect, Herpetic Keratitis
- Trial name
- NCT04420429
- Testing
- Descemet membrane endothelial keratoplasty (DMEK)
- Where
- Turkey (Türkiye)
- Volunteers
- 43 people
- Sponsor
- Beyoglu Eye Research and Education Hospital
Corneal Edema, Fuchs' Endothelial Dystrophy
PVEK Corneal Implant For Treatment of Corneal Edema
The goal of this clinical trial is to learn if PVEK, a corneal implant , is safe and well tolerated for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial…
- Conditions
- Corneal Edema, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dysfunction
- Trial name
- CIFRE (NCT07325097)
- Testing
- Precise Vision Endothelial Keratoplasty (PVEK) Implant
- Where
- 3 sites in Armenia, Israel
- Volunteers
- 15 people
- Sponsor
- Precise Bio