Life 4°C Versus Optisol in Corneal Storage Media

Completed · Phase 3

Conditions studied: Complications of Corneal Transplant

In brief

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.

Key facts

Study ID

NCT01657500

Run by

University Hospitals Cleveland Medical Center

People needed

64

Starts

2011-06-01

Expected to finish

2012-10-01

Last updated by the study team

2022-04-18

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Price Vision Group — Indianapolis, Indiana, United States
• Verdier Eye Center — Grand Rapids, Michigan, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Central Pennsylvannia Eye Institute — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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