Post Market Clinical Follow Up

STEM ALPHA

Clinical results of KT

 

Influence of organoculture medium on the clinical results of  transfixiant keratoplasty (KT)

 

Coralie Ouilhon; Under the direction of Anne-Sophie Marty, 2017LYO1M206 - 2017

(Presentation SFO 2018, 5 - 8 May)

 

Compare the influence of two organoculture media on the prognosis of Keratoplasty Transfixiante (KT). We conducted a Monocentric retrospective study, including patients who benefited from a transfixiante keratoplasty between 1 January 2008 and 31 December 2015 at the Edouard Herriot Hospital in Lyon. The grafts came from the cornea Bank of the Edouard Herriot Hospital. They were conserved in organoculture in a conventional conservation Medium (CorneaMax ®) or in a non-compound animal-based conservation media (STEMALPHA2 ®). Prior to grafting, the grafts were déturgescence in a conventional medium containing Dextran T500 (CorneaJet ®) or Poloxamer 188 (STEMLPHA3 ®). Endothelial cell densities (DCE) were compared as a function of conservation media at the beginning and end of conservation, followed by 6, 12, 24, and 36 months after intervention. The main judgement criterion was endothelial decay at 12 months. The secondary judgement criteria were the best corrected visual acuity (CAVM), corneal astigmatism, minimal corneal thickness, and complications. Five hundred and Thirty-nine KT were included, of which 247 were in the StemAlpha group. The daily endothelial loss during conservation was lower in the StemAlpha group (0.19 vs. 0.31, p < 0.001). Endothelial decay at 12 months was 42.34% in the Cornea group and 36.94% in the StemAlpha Group (p = 0,138). There was no statistically significant difference in CAVM, corneal astigmatism, pachymetry, and intraocular pressure between the two groups. The STEMALPHA2 ® conservation medium improves health safety and induces less endothelial cellular lesions during conservation. However, the contribution of Poloxamer 188 during the déturgescence phase on postoperative endothelial decay was not highlighted.

G. Ho Wang Yin_J Fr Ophtalmol_2016

G. Ho Wang Yin_J Fr Ophtalmol_2016

Impact des caractéristiques du greffon cornéen sur les résultats cliniques après Descemet stripping automated endothelial keratoplasty (DASEK).

 

Effect of donor graft characteristics on clinical outcomes in Descemet stripping automated endothelial keratoplasty (DASEK). 

R Hristova et al, 2016

ЕX VIVO EXPANDED LIMBAL STEM CELLS – THE

ЛИМБАЛНА БИОПСИЯ След получаване на информирано съгласие бе проведена минимално инвазивна лимбална биопсия. Процедурата включва внимателна дисекция на лимбален епител с размер 2х2 мм в зона с демонстративни палисади на Vogt на 12 ч. при стриктно спазване на асептични условия. В два от случаите за донор бе използвано контралатералното здраво око. При другите двама пациенти биопсията бе получена от зона със запазени палисади на засегнатото око. Полученият материал бе транспортиран до тъканна банка Биорегенерация в среда Stem α 2 (STEM ALPHA, Rhône-Alpes, France).

 

ЕX VIVO EXPANDED LIMBAL STEM CELLS – THERAPEUTIC APPLICATION

R. Hristova, Y. Zdravkov, M. Hristova, I. Tanev

 

The aim of the current study is to investigate the application of autologous ex vivo expanded limbal stem cell transplantation in the management of ocular surface disease. This is the fi rst study in Bulagria in which autologous ex vivo expanded stem cells were transplanted to four patients with mean age 56.5 years from the Department of Ophthalmology, University Hospital Alexandrovska. All patients presented signs of unilateral limbal stem cell defi ciency, associated with trophic disease of the ocular surface. After informed consent was obtained a minimally invasive limbal biopsy was performed. The limbal materials were cultured using a novel protocol without additional xenobiotic products. The grafts were transplanted after fourteen days. Anterior segment optical coherence tomography before and after the intervention was used for assessment of the condition. Success of the procedure was defi ned as 1  . complete epithelialization of the corneal surface, 2. partial or complete reduction of neovascularization, 3. achieving normal corneal transparency, thickness and refl ex, 4. visual acuity improvement. Clinical recovery was observed in all patients, as well as improvement of subjective ocular comfort. In three of the cases all four success criteria were met. Visual acuity of one patient did not change, due to neoplastic process, pervading the optic nerve. No graft rejection reactions were observed. Limbal biopsy did not induce limbal stem cell defi ciency in the donor eye. Transplantation of autologous ex vivo expanded limbal stem cells is an effective and safe method for ocular surface reconstruction, which can be applied in different conditions, associated with limbal stem cell defi ciency.

 

Contact address: Rozaliya Hristova, 1 G. Sofi iyski str. Sofi a 1431 е-mail: alleta@abv.bg

Comparative study

Hung J, et al. Stem Alpha versus Eurobio : comparaison à un an des résultats de 49 kératoplasties transfixiantes. SFO Mai 2016.

Résumé : Contexte : Afin d’étudier l’efficacité et la sécurité clinique d’un milieu de conservation en organoculture intégralement synthétique, nous avons mené une étude post-greffe comparative entre des patients receveurs de greffons conservés dans les milieux standards contenant des substances d’origine animale et ceux receveurs de greffons des milieux Stem Alpha. Méthode : Une étude rétrospective a été réalisée par inclusion consécutive de 49 patients ayant bénéficié d’une kératoplastie transfixiante (KTF) à but optique du 1er janvier 2013 au 30 juillet 2014 au CHRU de Lille opérés par deux chirurgiens, et suivis pendant un an. Une analyse descriptive et comparative a été menée. Nous avons recueilli 26 greffons conservés dans les milieux Eurobio et 23 greffons des milieux Stem Alpha. Résultats : Nous n’avons pas retrouvé de différence significative concernant les résultats visuels (acuité visuelle à un an 3,50 +/- 2,7 vs 3,84 +/-2, p=0,66), ni en terme de complications (échecs primaires, infection, hypertonie oculaire, décompensation endothéliale, rejet…), ni d’astigmatisme (4,9 +/- 2,4 D vs 4,5 +/- 2,0 D, p=0,66). Nous avons cependant noté une différence significative quant à la densité cellulaire endothéliale plus importante dans le groupe Stem Alpha, révélée dès le comptage préopératoire (2522 vs 2246 p<0,001) et cette différence se maintient significativement à 6 mois (1770 vs 1142 p=0,009) et à un an (1525 vs 1020 p=0,031) après la KTF.

Conclusion : Les greffons conservés dans les milieux Stem Alpha donnent des résultats visuels identiques au milieu standard à un an de suivi. En outre, ils permettent une meilleure préservation des cellules endothéliales. 

 

 

A-S Marty, C Burillon, A Desanlis, O Damour, V Kocaba, C Auxenfans. Validation of an endothelial roll pr,eparation for Descemet Membrane Endothelial Keratoplasty by a cornea bank using 'no touch' dissection technique. Cell and Tissue Banking, pp 1-8, 2016. Spinger link : http://link.springer.com/article/10.1007/s10561-016-9544-y

 

In vivo structural imaging of the cornea by polarization-resolved second harmonic microscopy

Gaël Latour,1 Ivan Gusachenko,1 Laura Kowalczuk,2 Isabelle Lamarre,1 and Marie‑Claire Schanne-Klein1,*

1Laboratory for Optics and Biosciences, École Polytechnique—CNRS—INSERM, 91128 Palaiseau, France

2Laboratory for Applied Optics, ENSTA ParisTech—École Polytechnique—CNRS, 91761 Palaiseau, France *Corresponding author: marie-claire.schanne-klein@polytechnique.edu

Received 7 Nov 2011; revised 29 Nov 2011; accepted 29 Nov 2011; published 1 Dec 2011

(C) 2011 OSA 1 January 2012 / Vol. 3, No. 1 / BIOMEDICAL OPTICS EXPRESS 1

 

 

Delessalle N. et al, 2007. Contrôle de qualité externe des milieux utilisés dans la greffe de cornée : résultats des tours de contrôles de 2005 à 2006. AFSSAPS - DLC, unité Produits sanguins et thérapie cellulaire St denis et Microbiologie.

 

 


Thuret G., Manissolle C., Campos-Guyotat L, Guyotat D and Gain P. (2005) Animal compound free medium and poloxamer for human corneal organ culture and deswelling, Investigative Ophthalmology & Visual Science, 46, 816-822.

 


G. Thuret, C. Manissolle, O. Garraud, S. Acquart, L. Campos, D. Guyotat, J. Maugery and P. Gain. New animal compound free medium for human corneal organ culture, Invest Ophthalmol Vis Sci 2004 ; 45 : E-Abstract 4868.

EEBA 2014

ACF cornea storage media STEM ALPHA

STEM ALPHA is a medium without animal component that allows optimal preservation of endothelial cells with good tolerance and effectiveness of transplanted corneas.

Marie Regnier et al. Medicine 2017

Marie Regnier et al. Medicine 2017

Eye bank prepared versus surgeon cut endothelial graft tissue for Descemet membrane endothelial keratoplasty: An observational study.
Regnier, Marie MD a; Auxenfans, Celine PhD b; Maucort-Boulch, Delphine MD, PhD c,d,e; Marty, Anne-Sophie MD a; Damour, Odile PhD b; Burillon, Carole MD a,b,c; Kocaba, Viridiana MD a,b,c,*
[Article] Medicine. 96(19):e6885, May 2017. 

 

The purpose of this article is to examine outcomes of Descemet membrane endothelial keratoplasty (DMEK) performed with cornea bank (CB) prestripped tissue and surgeon stripped tissue (SST).

This retrospective study examined subjects who underwent DMEK with CB or surgeon prepared tissue for Fuchs endothelial corneal dystrophy. Best-corrected visual acuity (BCVA), corneal thickness, endothelial cell count (ECC), and complications were examined before and throughout a 6-month postoperative period.

Eleven CB and 22 SST subjects were included. Six months after surgery, BCVA was 20/20 or better in 36.4% of CB and 22.7% of SST subjects (P = .43). Median logMAR BCVA was 0.10 (0.00-0.20, 20/25) in group CB and 0.10 (0.10-0.30, 20/25) in group SST. Median preoperative corneal thickness was 614.0 [mu]m (577.5-662.0 [mu]m) and 658.0 [mu]m (606.0-689.0 [mu]m) in CB and SST subjects, respectively (P = .37). Six months after surgery, median corneal thickness was lower in the CB group (571.0 [mu]m [478.0-592.0 [mu]m]), than in the SST group (576.0 [mu]m [531.0-607.0 [mu]m], P = .02). At 6 months, median ECC was 1500.0 cell/mm2 (1321.5-2049.0 cell/mm2, 41% decrease) in group CB and 1403.0 cell/mm2 (972.5-2010.7 cell/mm2, 46% decrease) in group SST (P = .70). Rebubbling was required in 5 CB (45.5%) and 15 SST (68.2%) subjects (P = .39).

Fuchs' dystrophy patients have good anatomic and functional DMEK results. Similar outcomes and complication rates occurred with eye bank and surgeon prepared donor tissue.

 

An-Katrien De Roo et al, ivos 2017

An-Katrien De Roo et al, ivos 2017

Identification of Circulating Fibrocytes and Dendritic Derivatives in Corneal Endothelium of Patients With Fuchs’ Dystrophy

Bogdan Spiru et al, Cornea 2017

Bogdan Spiru et al, IVOS Cornea 2017

Biomechanical Differences Between Femtosecond Lenticule Extraction (FLEx) and Small Incision Lenticule Extraction (SmILE) Tested by 2D-Extensometry in Ex Vivo Porcine Eyes Bogdan Spiru; Sabine Kling; Farhad Hafezi; Walter Sekundo  

Investigative Ophthalmology & Visual Science May 2017, Vol.58, 2591-2595. doi:10.1167/iovs.16-20211

 

Abstract

Purpose: To evaluate the biomechanical stability of ex vivo porcine corneas after femtosecond lenticule extraction (FLEx) and small incision lenticule extraction (SmILE) refractive surgeries.

Methods: Forty-five porcine eyes were equally divided into three groups: Groups 1 and 2 were treated with FLEx and SmILE procedure, respectively. Group 3 served as control. A refractive correction of −14 diopters (D) with a 7-mm zone using either a 160-μm flap (FLEx) or a 160-μm cap (SmILE) was performed. For two-dimensional (2D) elastic and viscoelastic biomechanical characterization, two testing cycles (preconditioning stress–strain curve from 1.27 to 12.5 N, stress–relaxation at 12.5 N during 120 seconds) were conducted. Young's modulus and Prony constants were calculated.

Results: At 0.8% of strain, FLEx (370 ± 36 kPa) could resist a significantly lower stress than SmILE (392 ± 19 kPa, P = 0.046) and the control group (402 ± 30 kPa, P = 0.013). Also, FLEx (46.1 ± 4.5 MPa) had a significantly lower Young's modulus than the control group (50.2 ± 3.4 MPa, P = 0.008). The Young's modulus of SmILE (48.6 ± 2.5 MPa) had values situated between untreated corneas and FLEx-treated corneas. When compared to untreated controls, the stress resistance decreased by 8.0% with FLEx and 2.5% with SmILE; Young's modulus decreased by 5.1% with FLEx and 1.04% with SmILE. With a cap-based procedure, both anterior cap and stromal bed carry the intraocular pressure, while in a flap-based procedure, only the stromal bed does.

Conclusions: Compared to flap-based procedures like FLEx, the cap-based technique SmILE can be considered superior in terms of biomechanical stability, when measured experimentally in ex vivo porcine corneas. 

Benoit_JMBBM_2016

Benoit_JMBBM_2016

Simultaneous microstructural and mechanical characterization of human corneas at increasing pressure. JMBBM 2016