Randomized, Prospective, Single-Masked Clinical Trial of Endothelial Keratoplasty Performance With 2 Donor Cornea 4°C Storage Solutions and Associated Chambers

Price, Marianne O.; Knight, O'Rese J; Benetz, Beth Ann; Debanne, Sara M.; Verdier, David D.; Rosenwasser, George O. D.; Rosenwasser, Miriam; Price, Francis W.; Lass, Jonathan H.

doi:10.1097/ico.0000000000000354

Cited by 24 publications

(19 citation statements)

References 12 publications

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“…In 2013, of the 62,274 USA-generated donor tissues for either PKP or EK, 18,355 (29%) were exported. 5 The introduction of Life 4°C (Numedis, Isanti, MN) in the United States in 2010, another chondroitin-based intermediate storage medium approved by the FDA for 14-day PT with reportedly improved endothelial viability, 29 has also not had an impact on this domestic practice pattern, because it represents only a small percentage of the 4°C storage solutions used by eye banks.…”

Section: Discussionmentioning

confidence: 99%

Cornea Preservation Time Study

Lass

Szczotka-Flynn

Ayala

et al. 2015

Cornea

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Purpose Describe the aims, methods, donor and recipient cohort characteristics, and potential impact of the Cornea Preservation Time Study (CPTS). Methods The CPTS is a randomized, clinical trial conducted at 40 clinical sites (70 surgeons) designed to assess the effect of donor cornea preservation time (PT) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK). Eyes undergoing surgery for Fuchs’ dystrophy (FECD) or pseudophakic bullous keratopathy were randomized to receive donor corneas stored ≤7 days or 8–14 days. Donor and patient characteristics, tissue preparation and surgical parameters, recipient and donor cornea stroma clarity, central corneal thickness, intraocular pressure, complications, and a reading center-determined central endothelial cell density were collected. Surveys were conducted to evaluate pre-CPTS PT practices. Results The 1,330 CPTS donors were: 49% >60 years old, 27% diabetic, a median eye bank-determined screening ECD of 2,688 cells/mm2, and 74% eye-bank-prepared for DSAEK. 1,090 recipients (1,330 eyes including 240 bilateral cases) had: median age of 70 years, 60% female, 90% Caucasian, 18% diabetic, 52% phakic, and 94% with FECD. Prior to the CPTS, 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010–11; 96% were preserved ≤ 7 days. Of 305 AAO members responding to a pre-CPTS survey, 233 (76%) set their maximum PT preference at 8 days or less. Conclusions The CPTS will increase understanding of factors related to DSAEK success and, if non-inferiority of longer PT is shown, will have a great potential to extend the available pool of endothelial keratoplasty donors.

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Section: Discussionmentioning

confidence: 99%

Cornea Preservation Time Study

Lass

Szczotka-Flynn

Ayala

et al. 2015

Cornea

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“…Price et al stored the tissues randomly in Life4°C or Optisol-GS for a maximum period of 7 days to be used for EK. 37 There was no difference between Life4°C and Optisol-GS groups in terms of endothelial cell loss (ECL) at 6 months after the surgery (18% and 20% ECL from Life 4°C and Optisol-GS group respectively). Recipients' stroma and grafts remained clear during the 6-month follow-up.…”

Section: Hs For Ekmentioning

confidence: 89%

“…Although it was suggested that Life4°C behaves similar to Optisol-GS, it has been shown that the addition of glutathione in Optisol-GS facilitates the performance and prolongs the quality of the graft. 37 Lass et al 39 showed that after 3 years of follow-up, the ECL was 37.3% and 39.7% when the tissues were stored for 0-7 days and 8-14 days respectively, which was found to be statistically different.…”

Section: Hs For Ekmentioning

confidence: 98%

“…35,36 Life4°C (Numedis Inc; Isanti, MN, USA) solution, which is currently used by many eye banks in the United States, has also been studied and recommended. 37 Another alternative to Optisol-GS, not commercially available, is Chen medium (CM; Chen Laboratories, noncommercial product), a FDA-approved isotonic storage solution for corneal tissue. 32 It contains TC199 culture medium with reduced sodium chloride and without bicarbonates.…”

Section: Variety Of Storage Solutions Available For Hsmentioning

confidence: 99%

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Corneal storage methods: considerations and impact on surgical outcomes

Wojcik

Ferrari

Romano

et al. 2020

Expert Review of Ophthalmology

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Introduction: With recent developments in the field of eye banking, human corneas are not only procured and preserved, but also processed and prepared for transplantation. However, one of the challenges that still persist is the long-term storage of tissues without damaging the corneal endothelial cells. Thus, the review aims at reporting the influence of tissue storage conditions on the clinical outcomes.Areas covered: Endothelial cell loss (ECL), graft survival and contamination from the tissues stored in hypothermic storage and organ culture and; other storage options such as cryopreservation and lyophilization.Expert opinion: Hypothermic storage and organ culture have shown similar ECL. However, due to relatively new techniques and limited long-term clinical studies, further evaluation is essential to assess the effect of storage time and conditions on the grafts deemed for endothelial keratoplasty.

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“…Resource centers with similar roles for other types of images have become common as new imaging methods have been developed and implemented clinically to monitor the effects of treatment. They have been widely used in oncology (Chauvie et al 2014;Gopal et al 2016) and ophthalmology trials (Siegel and Milton 1989;Danis 2009;Price et al 2015;Toth et al 2015;Domalpally et al 2016;Rosenfeld et al 2018) but also in trials in other medical settings (Desiderio et al 2006;Ahmad et al 2016).…”

Section: Other Resource Centersmentioning

confidence: 99%

Centers Participating in Multicenter Trials

Scherer¹,

Hawkins²

2020

Principles and Practice of Clinical Trials

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Successful conduct of multicenter trials requires many different types of activities, implemented by different types of centers. Resource centers are those involved in planning the trial protocol, overseeing trial conduct, and analyzing and interpreting trial data. They include clinical and data coordinating centers, reading centers, central laboratories, and others. Clinical centers prepare for the trial at their setting and accrue, treat, and follow up study participants. Each center

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Randomized, Prospective, Single-Masked Clinical Trial of Endothelial Keratoplasty Performance With 2 Donor Cornea 4°C Storage Solutions and Associated Chambers

Abstract: Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4°C.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657500.

Cited by 24 publications

References 12 publications

Cornea Preservation Time Study

Cornea Preservation Time Study

Corneal storage methods: considerations and impact on surgical outcomes

Centers Participating in Multicenter Trials

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