Functional antigen matching in corneal transplantation
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Functional antigen matching in corneal transplantation : matching for the HLA-A, -B and -DRB1 antigens (FANCY) - study protocol. / Böhringer, Daniel; Ihorst, Gabriele; Grotejohann, Birgit; Maurer, Julia; Spierings, Eric; Reinhard, Thomas; FANCY study group; Linke, Stephan.
in: BMC OPHTHALMOL, Jahrgang 14, 2014, S. 156.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Functional antigen matching in corneal transplantation
T2 - matching for the HLA-A, -B and -DRB1 antigens (FANCY) - study protocol
AU - Böhringer, Daniel
AU - Ihorst, Gabriele
AU - Grotejohann, Birgit
AU - Maurer, Julia
AU - Spierings, Eric
AU - Reinhard, Thomas
AU - FANCY study group
AU - Linke, Stephan
PY - 2014
Y1 - 2014
N2 - BACKGROUND: Penetrating keratoplasty can commonly restore vision in corneal blindness. However, immunological graft reactions may induce irreversible graft failure in a substantial percentage. Repeat keratoplasties in turn are associated with increased risk of graft failure and possibly irreversible blindness. Topical as well as systemic immunosuppressants are administered for prophylaxis. However, severe adverse effects limit long-term usage. By contrast, matching for transplantation antigens might be effective for a long time.METHODS: FANCY is a prospective, controlled, randomised, double-blind, multi-centre clinical trial with two parallel arms. The primary objective is to evaluate superiority of the proposed HLA matching strategy in comparison to random graft assignment with respect to the primary endpoint 'time to first endothelial graft rejection'. Relevant inclusion criteria are age over 18 years and waiting for penetrating or endothelial lamellar keratoplasty. The most important exclusion criteria are abuse of medication and/or drugs and an anticipated waiting time for an HLA match longer than 6 months. After randomisation, patients either receive a HLA-matched graft (experimental intervention) or a random graft (control intervention). The calculated sample size is 620 patients. The trial started in 2009 with a recruitment period of 24 months. A total of 654 patients were included during this time.DISCUSSION: The primary goal of FANCY is to assess whether histocompatibility matching is feasible and effective in the broad clinical routine. However, during the course of the trial, the landscape of keratoplasty changed due to the rise of Descemet Membrane Endothelial Keratoplasty (DMEK). Nowadays, immune reactions are confined mostly to the 'high-risk' subgroups. If we would design FANCY in 2014, we would narrow down the inclusion criteria to include only the high risk patients and accept longer waiting times for a matching donor here.TRIAL REGISTRATION: The unique identifying number of the FANCY trial is NCT00810472.
AB - BACKGROUND: Penetrating keratoplasty can commonly restore vision in corneal blindness. However, immunological graft reactions may induce irreversible graft failure in a substantial percentage. Repeat keratoplasties in turn are associated with increased risk of graft failure and possibly irreversible blindness. Topical as well as systemic immunosuppressants are administered for prophylaxis. However, severe adverse effects limit long-term usage. By contrast, matching for transplantation antigens might be effective for a long time.METHODS: FANCY is a prospective, controlled, randomised, double-blind, multi-centre clinical trial with two parallel arms. The primary objective is to evaluate superiority of the proposed HLA matching strategy in comparison to random graft assignment with respect to the primary endpoint 'time to first endothelial graft rejection'. Relevant inclusion criteria are age over 18 years and waiting for penetrating or endothelial lamellar keratoplasty. The most important exclusion criteria are abuse of medication and/or drugs and an anticipated waiting time for an HLA match longer than 6 months. After randomisation, patients either receive a HLA-matched graft (experimental intervention) or a random graft (control intervention). The calculated sample size is 620 patients. The trial started in 2009 with a recruitment period of 24 months. A total of 654 patients were included during this time.DISCUSSION: The primary goal of FANCY is to assess whether histocompatibility matching is feasible and effective in the broad clinical routine. However, during the course of the trial, the landscape of keratoplasty changed due to the rise of Descemet Membrane Endothelial Keratoplasty (DMEK). Nowadays, immune reactions are confined mostly to the 'high-risk' subgroups. If we would design FANCY in 2014, we would narrow down the inclusion criteria to include only the high risk patients and accept longer waiting times for a matching donor here.TRIAL REGISTRATION: The unique identifying number of the FANCY trial is NCT00810472.
KW - Clinical Protocols
KW - Cornea
KW - Double-Blind Method
KW - Graft Rejection
KW - Graft Survival
KW - HLA-A Antigens
KW - HLA-B Antigens
KW - HLA-DRB1 Chains
KW - Histocompatibility Antigens
KW - Histocompatibility Testing
KW - Humans
KW - Immunosuppressive Agents
KW - Keratoplasty, Penetrating
KW - Prospective Studies
KW - Research Design
KW - Transplantation Tolerance
U2 - 10.1186/1471-2415-14-156
DO - 10.1186/1471-2415-14-156
M3 - SCORING: Journal article
C2 - 25496165
VL - 14
SP - 156
JO - BMC OPHTHALMOL
JF - BMC OPHTHALMOL
SN - 1471-2415
ER -