Phase 3
N=64
Life 4°C Versus Optisol in Corneal Storage Media
Complications of Corneal Transplant
Bottom Line
View on ClinicalTrials.gov: NCT01657500 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Endothelial Cell Loss Post EK for Donor Corneas Preserved in Life 4°C and Optisol GS Corneal Storage Media — 20; 18 % endothelial cell loss — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Corneal donor storage in Optisol GS media solution (Other); Life 4°C solution for cornea storage (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Cell Loss Post EK for Donor Corneas Preserved in Life 4°C and Optisol GS Corneal Storage Media |
20; 18 | < 0.05 sig |
Summary
The purpose of this study is to compare the success of storing a donor cornea in Optisol GS, the current standard vs. storing the donor cornea in Life4°C, a newer solution. The donor cornea to be used for EK will be provided by an eye bank and will have been stored in either an Optisol GS solution or a Life 4°C solution. At 6 months, the doctors will determine whether there are any comparable differences in cell loss and graft clarity between the two donor corneas.
Eligibility Criteria
Inclusion Criteria
- Subjects undergoing EK for FECD only.
- Age range of 30-85 years with minimum life expectancy of at least 1 year
- Willingness to return to study site at 1 month, 3 months, and 6 months to complete study procedures
- Permissible EK procedures with preoperative diagnoses
- Pseudophakic FECD with posterior capsule supported or suture-fixated posterior chamber intraocular lens (IOL)
- Phakic FECD
- EK, phacoemulsification with posterior chamber IOL for phakic FECD with cataract
- Stromal vascularization is acceptable
- Controlled glaucoma on medication and/or previous trabeculectomy and laser trabeculoplasty is acceptable
Exclusion Criteria
- Since EK is suitable only for corneal conditions with endothelial dysfunction, all corneal conditions not associated with endothelial failure that are managed with PKP only are excluded (e.g. keratoconus, stromal dystrophies, traumatic corneal scars).
- Other exclusions include:
- Other primary endothelial dysfunction conditions including pseudophakic bullous keratopathy not due to FECD, posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
- Pseudophakic FECD with open loop anterior chamber IOL
- Previous failed keratoplasty, either EK or PKP
- Central subepithelial or stromal scarring detected preoperatively that could impact graft clarity assessment
- Anterior or peripheral anterior synechiae
- Uncontrolled glaucoma > 25 Hg with or without prior filtering surgery or shunt placement.
- Controlled glaucoma with tube shunt placement.
- Uncontrolled Uveitis - Fellow eye visual acuity < 20/200
- Fellow eye already included in the study
Data sourced from ClinicalTrials.gov (NCT01657500). 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.