Phase 4
N=1,405
Cornea Preservation Time Study
Cornea Preservation Time · Endothelial Keratoplasty · Transplant Success · Endothelial Cell Density
Bottom Line
View on ClinicalTrials.gov: NCT01537393 ↗Enrolled (actual)
1,405
Serious AEs
0.2%
Results posted
Apr 2018
Primary outcome: Primary: Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery — 30; 49 Eyes — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cornea tissue transplant (Biological)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery |
30; 49 | 0.02 sig |
| PRIMARY Endothelial Cell Density (ECD) |
1722; 1642 | 0.03 sig |
Summary
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.
Eligibility Criteria
Study Participant Eligibility Criteria
- Study Participant Inclusion Criteria
- Age range 30- 60 days after the initial enrollment visit, a new Baseline Visit and eligibility assessment will have to be performed.
- Presence of a condition related to endothelial dysfunction which will be treated by EK.
- Eligible indications for EK include:
- Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:
- Phakic FECD
- Phakic FECD with cataract
- Triple procedure including EK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed
- Aphakic FECD
- Pseudophakic FECD with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL
- Aphakic or pseudophakic corneal edema with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL without FECD
- Study Eye Exclusion Criteria
- Prior EK
- Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars)
- Presence of a condition that has a very high probability for failure (e.g., failed EK or Penetrating Keratoplasty (PKP), heavily vascularized cornea, uncontrolled uveitis)
- Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
- Anterior chamber IOL in study eye prior to or anticipated during EK
- Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK
- Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
- Stromal vascularization that is visually significant (by investigator's judgment)
- Presence of anterior synechiae (iris to cornea)
- Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
- Hypotony (Intraocular pressure 25mm Hg) glaucoma with or without prior filtering surgery or shunt or mini-shunt placement.
- A shunt or mini-shunt is any device implanted to lower intraocular pressure through an external route (e.g Ahmed) or internal route (e.g. Glaukos) that is present in the anterior chamber angle or extends into the anterior chamber.
- Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma
- Note: FECD or pseudophakic/aphakic corneal edema with posterior chamber IOL that also have undergone filtering surgery (without shunt or mini-shunt) in which glaucoma is currently considered under control will be eligible
- Fellow eye visual acuity < 20/200 that is not correctable with EK
Eligibility Criteria for Second Study Eye
- Study participant has already enrolled one eye
- The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3)
- EK surgery in second eye is not planned within 6 weeks of EK on first study eye
Data sourced from ClinicalTrials.gov (NCT01537393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.