Kerasave

What is KERASAVE?

KERASAVE is a completely synthetic media for corneal storage at 4°C for up to 14 days.

The solution contains two antibiotics.

The packaged also includes a sterile blister of 12 Amphotericin B tablets for an effective antifungal activity.

The phenol red indicator allows a rapid visualization of pH variations.

The optically clear vial bottom allows to evaluate cornea by specular microscopes (e.g. Konan, Hailabs) with no need to transfer it to another container, thus reducing the risk of contamination.

Stability studies demonstrated that KERASAVE is stable up to 5 days at high temperatures and up to 30 days at room temperature. Therefore, it can stand peak temperatures for the necessary transport and consignment time.

DEC are ocular prostheses for cosmetic reconstructions of the donor eye, after corneal excision. The product can be used together with disinfectants and preserves the normal shape of the eyelid successfully.

DEPLIANT

Depliant Kerasave_ENG 2.64 MB 630 downloads

The depliant of Kerasave. ...

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Indications of use

CORNEAL STORAGE AT 4°C WITH PRESERVATIVES INCLUDING ANTIFUNGALS

Characteristics

ENDOTOXIN-TESTED
SHELF-LIFE: 24 MONTHS
DURATION OF USE: UP TO 14 DAYS
CE MARK: 0477
FDA DE NOVO GRANT

VIDEO TUTORIAL

Technical documents

CE Certificate 335.83 KB 2243 downloads

AL.CHI.MI.A. S.R.L. production quality system is compliant with Annex Il (excluding...

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Technical Sheet - KER 002-00 516.78 KB 376 downloads

KERASAVE_Medium for corneal storage at 4°C + 12 vial pack + 1 blister pack of 12...

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Publications and Presentations

Corneal Storage Media with Amphotericin-B: Results from a Prospective Laboratory Study Submitted for Class 2 De Novo 510(k) Premarket Approval
Year: 2022, Cornea and Eye Banking Forum Authors: Tran K., PhD Co-authors: Ellison M.S., BA, BS; Straiko M.M.W., PhD; Giurgola L., MSc; Gatto C., MSc; Prof. Ragazzi E., MD; D’Amato Tothova J. [...]
Killing efficacy of a new hypothermic corneal storage medium Kerasave at 4°C against nine micro-organisms frequently found in donor corneas
Year: 2022, European Eye Bank Association (EEBA) Authors: Giurgola L.; Gatto C.; Rossi O.; D'Amato Tóthová J. PURPOSE The aim of the present study was to determine the killing efficacy of Kerasave [...]
Killing efficacy of a new hypothermic corneal storage medium against the micro-organisms frequently found in human donor cornea intended for transplantation
Year: 2021 Authors: Giurgola L.; Gatto C.; Honisch C.; Rossi O.; Ragazzi E.; D'Amato Tóthová J. BMJ Open Ophthalmology 10.1136/bmjophth-2021-000833 Online version This is a: Publication Objective: To [...]
A new storage medium containing amphotericin B versus Optisol-GS for preservation of human donor corneas
Year: 2020 Authors: Mistò R.; Giurgola L.; Pateri F.; Limongelli A.; Ragazzi E.; D’Amato Tóthová J. British Journal of Ophthalmology 2020, Nov 10 doi: 10.1136/bjophthalmol-2020-317136 Online version This is a: Publication Background/Aim: We [...]
Performance of New Hypothermic Corneal Storage Media With an Antimycotic Tablet in Comparison to Traditional Hypothermic Media During Simulated Eye Bank Processing
Year: 2020 Authors: Perry I.; Peterson K.; D'Amato Tóthová J.; Tramber M.; Botsay S.; Tremblay D. Cornea: April 13, 2020 - Volume Publish Ahead of Print doi: 10.1097/ICO.0000000000002333 Online version This is a: [...]
Comparison of the Performance of Traditional Cold Corneal Storage Media to a New Cold Corneal Storage Media with Antimycotic Tablet
Year: 2020, EEBA Authors: Perry I.; Peterson K.; Tremblay D.; Tramber M.; Botsay S.; D’Amato Tóthová J. Purpose: To compare the performance of Kerasave and Optisol GS corneal storage media across metrics of [...]
Antimycotic efficacy and safety of a new cold corneal storage medium by time–kill and toxicity studies
Year: 2019 Authors: Giurgola L.; Gatto C.; Parel J.M.; Miller D.; DʼAmato Tóthová J. Cornea. 2019 Oct;38(10):1314-1321. doi: 10.1097/ICO.0000000000002068 Online version This is a: Publication Purpose: To evaluate a [...]
Efficacy and Safety of Various Amphotericin B Concentrations on Candida albicans in Cold Storage Conditions
Year: 2019 Authors: K. D. Tran, PhD; B. T. Aldrich, PhD; J. D’Amato Tóthová, PhD; J. M. Skeie, PhD; C. M. Kondratick, PhD; L. Giurgola, MSc; C. Gatto, MSc, C. R. Reed, RN, PhD; G. A. [...]
Efficiency evaluation of the New Cold Cornea Storage Medium with Dissolvable Antifungal Tablet
Year: 2018, Cornea and Eye Banking Forum Authors: Eric Abdullayev MD, MBA, CEBT, Lions Eye Institute for Transplant and Research Purpose: Cold storage is the standard for corneal preservation method in the U.S., but none [...]
Efficacy of varying Amphotericin-B concentrations against Candida albicans after short exposure times in cold storage
Year: 2018, Cornea and Eye Banking Forum Authors: Khoa D. Tran, PhD, Lions VisionGift, Portland, USA Co-Authors: Terry M.A.; Giurgola L.; Gatto C.; D'Amato Tóthová J. Purpose: To determine the efficacy and safety of different Amphotericin-B (AmphoB) concentrations [...]

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Corneal Chamber containing Eusol-C is a completely synthetic medium for corneal storage at 4°C for up to 14 days. It also contains DEC, ocular prostheses for cosmetic reconstructions of the d [...]
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Packaging: Vial
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TISSUE-C is a medium for organ culture of donor cornea at 31°C for up to 1 month. It also contains CornealFloat, which is intended to suspend the cornea in the medium during organ cu [...]
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CARRY-C

Packaging: Vial
Items: 12
Volume: 50 ml

CARRY-C is a medium for corneal deswelling and transport at room temperature for up to 5 days.

Category: Corneal storage at 31°CEye banking

What is KERASAVE?

DEPLIANT

Depliant Kerasave_ENG 2.64 MB 630 downloads

Indications of use

Characteristics

VIDEO TUTORIAL

Technical documents

CE Certificate 335.83 KB 2243 downloads

Technical Sheet - KER 002-00 516.78 KB 376 downloads

Publications and Presentations

Corneal Storage Media with Amphotericin-B: Results from a Prospective Laboratory Study Submitted for Class 2 De Novo 510(k) Premarket Approval

Killing efficacy of a new hypothermic corneal storage medium Kerasave at 4°C against nine micro-organisms frequently found in donor corneas

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

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

Performance of New Hypothermic Corneal Storage Media With an Antimycotic Tablet in Comparison to Traditional Hypothermic Media During Simulated Eye Bank Processing

Comparison of the Performance of Traditional Cold Corneal Storage Media to a New Cold Corneal Storage Media with Antimycotic Tablet

Antimycotic efficacy and safety of a new cold corneal storage medium by time–kill and toxicity studies

Efficacy and Safety of Various Amphotericin B Concentrations on Candida albicans in Cold Storage Conditions

Efficiency evaluation of the New Cold Cornea Storage Medium with Dissolvable Antifungal Tablet

Efficacy of varying Amphotericin-B concentrations against Candida albicans after short exposure times in cold storage

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