A Randomized, Prospective, Double Masked Clinical Trial of Life 4°C Versus Optisol GS Corneal Storage Media
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 64
- Locations
- 8
- Primary Endpoint
- Endothelial Cell Loss Post EK for Donor Corneas Preserved in Life 4°C and Optisol GS Corneal Storage Media
Study Overview
Brief 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.
Detailed Description
- Purpose/ Specific Aims
The purpose of this study is to compare the success of storing a donor cornea in Optisol GS, the current standard solution that the donor cornea is stored in prior to surgery versus storing the donor cornea in Life 4°C, a newer solution. Laboratory tests that led to the recent approval of this new storage solution by the Food and Drug Administration have suggested that this solution may support the health of the endothelial cells better than Optisol GS. While there is extensive in vitro and ex vivo data regarding Life 4°C and its transport chamber, there are no short or long term in vivo studies to examine its performance clinically and the relationship of its performance to Optisol GS and its transport chamber. This study has been designed to examine these questions.
1.1 STUDY OBJECTIVES Primary objective: To determine whether endothelial cell loss post EK is comparable 6 months postoperatively for donor corneas preserved in Life 4°C vs. Optisol GS corneal storage media
Secondary objective: To determine whether graft clarity post EK is comparable 6 months postoperatively for donor corneas preserved in Life 4°C versus Optisol GS corneal storage media 2. Background and Significance
Currently it is estimated by the Eye Bank Association of America (EBAA) that 3500 to 5000 Americans wait an average of 1-2 months to undergo penetrating or endothelial keratoplasty. The situation worldwide is considerably more complex, and the availability of tissue is much more limited. In view of this shortage of tissue, much research has been undertaken with a view towards prolonging donor storage time and yet maintaining a viable endothelium, which is crucial to successful transplantation. Extended preservation time has transformed corneal transplantation surgery into an elective procedure and has facilitated the availability of available donor tissue. However, corneal preservation involves many other factors in addition to simply increasing the length of donor storage time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Endothelial Cell Loss Post EK for Donor Corneas Preserved in Life 4°C and Optisol GS Corneal Storage Media
Time Frame: Six months
Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4°C.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jonathan Lass, M.D.
Charles I Thomas Professor and Chairman CWRU Department of Ophthalmology and Visual Sciences Director, University Hospitals Eye Institute
University Hospitals Cleveland Medical Center