A new storage medium containing amphotericin B versus Optisol-GS for preservation of human donor corneas

Abstract

Background/AimWe compared the quality of human donor corneas stored in a cold storage medium containing 2.5 μg/ml of amphotericin B (Kerasave, AL.CHI.MI.A. S.R.L., Ponte San Nicolò, Italy) and Optisol-GS (Bausch & Lomb Inc., Bridgewater, NJ, USA) for 14 days.MethodsSixteen pairs of human donor corneas were collected in Eusol-C (AL.CHI.MI.A. S.R.L., Ponte San Nicolò, Italy). Next, all tissues underwent the first evaluation that included the assessments of central corneal thickness (CCT), endothelial cell density (ECD) measured using both trypan blue staining and specular microscopy, endothelial cell (EC) mortality and morphology, and corneal transparency within 24 hours from recovery (Day 1). Afterwards, one cornea of each pair was transferred into Kerasave or Optisol-GS. ECD and CCT were also assessed at Day 7, and all the metrics were evaluated again at the end of the storage period (Day 14).ResultsAt all tested time points, no differences were found in the qualitative (corneal transparency, EC morphology) and quantitative metrics (ECD, CCT, EC mortality) between the Kerasave and the Optisol-GS storage groups. At Day 14, the corneas stored in Kerasave and Optisol-GS showed ECD of 2312±98 and 2335±128 cells/mm2 (p=0.886), CCT of 717±17 and 697±19 μm (p=0.454) and central EC mortality of 0.54%±0.40% and 0.14%±0.14% (p=0.719), respectively.ConclusionsThe new amphotericin B−containing medium Kerasave was comparable to Optisol-GS in terms of preservation of corneal characteristics at 2–8°C for 14 days.

Cold Storage Media versus Optisol-GS in the Preservation of Corneal Quality for Keratoplasty: A Systematic Review

“…The main characteristics of the included studies, such as storage conditions, time and temperature ranges, the comparative distinct exposition media, and the assessment methods are shown in Table 4. Of the 14 included studies, 13 evaluated the effect of preservation in human corneas [5,12,[22][23][24][25][26][27][28][29][30][31][32]; 1 study was performed with rabbit cornea for a preclinical evaluation of new intermediate storage media with simple formulations [8].…”

“…Optisol-GS was compared with seven distinct commercial media: Chen medium [31], Cornea Cold medium [13], Cornisol [22], Dexsol [25], Eusol-C [27], Kerasave [30,32], and Sinasol [26]. Optisol-GS was also compared with other compositions, such as a coconut water-based solution [23], Optisol-GS supplemented with antibiotics [24,28,29,33], and a minimum essential medium (MEM) with supplements [33].…”

“…The main components of the included cold cornea storage media are described in Tables 5 and 6. The most used components included: MEM (base medium) [13,22,[25][26][27]30,32], HEPES (buffer) [13,24,26,27,31], and the antibiotics gentamicin and streptomycin [13,22,26,[30][31][32]. The cell metabolism stimulant and hyperosmotic agent chondroitin sulfate is present in Optisol-GS, Dexsol [25], Sinasol [26], and other compositions [20].…”

“…Sodium pyruvate was also included as an energy source in Optisol-GS, Cornea Cold medium [13,35], Eusol-C [34], and Dexsol [25]. The use of sodium bicarbonate buffer was described for Optisol-GS, Kerasave [30,32], Cornisol [22], Cornea Cold medium (35), Eusol-C [27], Dexsol [25], and Sinasol [26]. Ascorbic acid was reported as an antioxidant agent in the composition of Optisol-GS.…”

Killing efficacy of a new hypothermic corneal storage medium against the micro-organisms frequently found in human donor cornea intended for transplantation

“…6 13-16 Kerasave (AL.CHI.MI.A Srl, Italy) is a newly developed medical device and Conformité Européenne (CE)-marked hypothermic storage medium containing amphotericin B, which is intended for storage of human donor corneas at 2°C-8°C for up to 14 days. 15 Kerasave's Food and Drug Administration approval is pending at the time of this submission.…”