Protein Profile of Immunoregulatory Factors in Diabetic Cataract
10 de abril de 2013 atualizado por: Danka Grcevic, University of Zagreb
The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens surgery complications.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The study compared the levels of several immunoregulatory molecules (vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), Fas Ligand (FasL), interleukin-10 (IL-10) and interleukin-17 (IL-17)) in serum and aqueous humor between type 2 diabetes mellitus patients, without clinically evident diabetic retinopathy or diabetic macular edema, and nondiabetic cataract patients.
Investigators also investigated whether concentrations of immunoregulatory molecules significantly correlated with intraoperative and postoperative parameters. Particularly, investigators focused on the development of corneal edema as one of the main causes of low visual acuity in the immediate postoperative period after intraocular lens implantation.
Since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens (IOL) surgery complications, the findings may be relevant for the development of therapeutic strategies aimed to restore protein profile of immunoregulatory factors in parallel to cataract treatment.
Tipo de estudo
Intervencional
Inscrição (Real)
61
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Brodsko-posavska zupanija
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Slavonski brod, Brodsko-posavska zupanija, Croácia, 35000
- Department of Ophtalmology, General Hospital "Dr. J. Bencevic"
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Grad Zagreb
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Zagreb, Grad Zagreb, Croácia, 10000
- Department of Physiology and Immunology, University of Zagreb School of Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- patients undergoing phacoemulsification combined with IOL implantation
- for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years
- for diabetic group: therapy with oral hypoglycemic agents for glycemic control
- no other ocular (retinal) or systemic diabetic complications of T2DM
Exclusion Criteria:
- patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma
- patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: senile cataract with NSAID
15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac. |
Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.
Outros nomes:
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Experimental: diabetic cataract with NSAID
17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac. |
Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.
Outros nomes:
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Sem intervenção: senile cataract without NSAID
17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. |
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Sem intervenção: diabetic cataract without NSAID
12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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serum level of interleukin-10
Prazo: 2 hours before the surgery
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2 hours before the surgery
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serum level of monocyte chemotactic protein-1
Prazo: 2 hours before the surgery
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2 hours before the surgery
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serum level of interleukin-17
Prazo: 2 hours before the surgery
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2 hours before the surgery
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serum level of Fas ligand
Prazo: 2 hours before the surgery
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2 hours before the surgery
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serum level of vascular endothelial growth factor
Prazo: 2 hours before the surgery
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2 hours before the surgery
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level of interleukin-10 in aqueous humor
Prazo: intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of monocyte chemotactic protein-1 in aqueous humor
Prazo: intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of interleukin-17 in aqueous humor
Prazo: intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of Fas ligand in aqueous humor
Prazo: intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of vascular endothelial growth factor in aqueous humor
Prazo: intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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degree of corneal edema
Prazo: preoperatively - 2 hours before the surgery
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preoperatively - 2 hours before the surgery
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degree of corneal edema
Prazo: postoperatively - day 1
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postoperatively - day 1
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degree of corneal edema
Prazo: postoperatively - day 8
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postoperatively - day 8
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degree of corneal edema
Prazo: postoperatively - week 3
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postoperatively - week 3
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degree of corneal edema
Prazo: postoperatively - month 3
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postoperatively - month 3
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Danka Grcevic, prof.,MD,PhD, University of Zagreb
- Investigador principal: Sanja Mitrovic, MD, Department of Ophthalmology, General Hospital "Dr. J. Bencevic"
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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- Klein BE, Klein R, Moss SE. Prevalence of cataracts in a population-based study of persons with diabetes mellitus. Ophthalmology. 1985 Sep;92(9):1191-6. doi: 10.1016/s0161-6420(85)33877-0.
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- Hernandez C, Segura RM, Fonollosa A, Carrasco E, Francisco G, Simo R. Interleukin-8, monocyte chemoattractant protein-1 and IL-10 in the vitreous fluid of patients with proliferative diabetic retinopathy. Diabet Med. 2005 Jun;22(6):719-22. doi: 10.1111/j.1464-5491.2005.01538.x.
- Stefek M, Karasu C. Eye lens in aging and diabetes: effect of quercetin. Rejuvenation Res. 2011 Oct;14(5):525-34. doi: 10.1089/rej.2011.1170. Epub 2011 Oct 6.
- Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6.
- Altintas AG, Yilmaz E, Anayol MA, Can I. Comparison of corneal edema caused by cataract surgery with different phaco times in diabetic and non-diabetic patients. Ann Ophthalmol (Skokie). 2006 Spring;38(1):61-5. doi: 10.1385/ao:38:1:61.
- Amon M, Menapace R, Scheidel W. Results of corneal pachymetry after small-incision hydrogel lens implantation and scleral-step incision poly(methyl methacrylate) lens implantation following phacoemulsification. J Cataract Refract Surg. 1991 Jul;17(4):466-70. doi: 10.1016/s0886-3350(13)80853-x.
- Brazitikos PD, Androudi S, Papadopoulos NT, Christen WG, Stangos NT. A-scan quantitative echography of senile cataracts and correlation with phacoemulsification parameters. Curr Eye Res. 2003 Sep;27(3):175-81. doi: 10.1076/ceyr.27.3.175.16051.
- Tabandeh H, Wilkins M, Thompson G, Nassiri D, Karim A. Hardness and ultrasonic characteristics of the human crystalline lens. J Cataract Refract Surg. 2000 Jun;26(6):838-41. doi: 10.1016/s0886-3350(00)00305-9.
- Schoenberger SD, Kim SJ, Sheng J, Rezaei KA, Lalezary M, Cherney E. Increased prostaglandin E2 (PGE2) levels in proliferative diabetic retinopathy, and correlation with VEGF and inflammatory cytokines. Invest Ophthalmol Vis Sci. 2012 Aug 27;53(9):5906-11. doi: 10.1167/iovs.12-10410.
- Tashimo A, Mitamura Y, Nagai S, Nakamura Y, Ohtsuka K, Mizue Y, Nishihira J. Aqueous levels of macrophage migration inhibitory factor and monocyte chemotactic protein-1 in patients with diabetic retinopathy. Diabet Med. 2004 Dec;21(12):1292-7. doi: 10.1111/j.1464-5491.2004.01334.x.
- Mine S, Okada Y, Tanikawa T, Kawahara C, Tabata T, Tanaka Y. Increased expression levels of monocyte CCR2 and monocyte chemoattractant protein-1 in patients with diabetes mellitus. Biochem Biophys Res Commun. 2006 Jun 9;344(3):780-5. doi: 10.1016/j.bbrc.2006.03.197. Epub 2006 Apr 17.
- Sung JK, Koh JH, Lee MY, Kim BH, Nam SM, Kim JH, Yoo JH, Kim SH, Hong SW, Lee EY, Choi R, Chung CH. Aldose reductase inhibitor ameliorates renal vascular endothelial growth factor expression in streptozotocin-induced diabetic rats. Yonsei Med J. 2010 May;51(3):385-91. doi: 10.3349/ymj.2010.51.3.385.
- Sawada O, Kawamura H, Kakinoki M, Sawada T, Ohji M. Vascular endothelial growth factor in the aqueous humour in eyes with myopic choroidal neovascularization. Acta Ophthalmol. 2011 Aug;89(5):459-62. doi: 10.1111/j.1755-3768.2009.01717.x. Epub 2010 Jan 22.
- Gao G, Li Y, Zhang D, Gee S, Crosson C, Ma J. Unbalanced expression of VEGF and PEDF in ischemia-induced retinal neovascularization. FEBS Lett. 2001 Feb 2;489(2-3):270-6. doi: 10.1016/s0014-5793(01)02110-x.
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- Okamura N, Ito Y, Shibata MA, Ikeda T, Otsuki Y. Fas-mediated apoptosis in human lens epithelial cells of cataracts associated with diabetic retinopathy. Med Electron Microsc. 2002 Dec;35(4):234-41. doi: 10.1007/s007950200027.
- Kim B, Kim SY, Chung SK. Changes in apoptosis factors in lens epithelial cells of cataract patients with diabetes mellitus. J Cataract Refract Surg. 2012 Aug;38(8):1376-81. doi: 10.1016/j.jcrs.2012.04.026. Epub 2012 Jun 23.
- Gregory MS, Repp AC, Holhbaum AM, Saff RR, Marshak-Rothstein A, Ksander BR. Membrane Fas ligand activates innate immunity and terminates ocular immune privilege. J Immunol. 2002 Sep 1;169(5):2727-35. doi: 10.4049/jimmunol.169.5.2727.
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- Sotozono C, Sano Y, Suzuki T, Tada R, Ikeda T, Nagata S, Kinoshita S. Soluble Fas ligand expression in the ocular fluids of uveitis patients. Curr Eye Res. 2000 Jan;20(1):54-7.
- Kovacic N, Grcevic D, Katavic V, Lukic IK, Marusic A. Targeting Fas in osteoresorptive disorders. Expert Opin Ther Targets. 2010 Oct;14(10):1121-34. doi: 10.1517/14728222.2010.522347.
- Berkkanoglu M, Guzeloglu-Kayisli O, Kayisli UA, Selam BF, Arici A. Regulation of Fas ligand expression by vascular endothelial growth factor in endometrial stromal cells in vitro. Mol Hum Reprod. 2004 Jun;10(6):393-8. doi: 10.1093/molehr/gah060. Epub 2004 Apr 8.
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- Devaraj S, Tobias P, Jialal I. Knockout of toll-like receptor-4 attenuates the pro-inflammatory state of diabetes. Cytokine. 2011 Sep;55(3):441-5. doi: 10.1016/j.cyto.2011.03.023. Epub 2011 Apr 16. Erratum In: Cytokine. 2011 Dec;56(3):832.
- Almeida DR, Khan Z, Xing L, Bakar SN, Rahim K, Urton T, El-Defrawy SR. Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. J Cataract Refract Surg. 2012 Sep;38(9):1537-43. doi: 10.1016/j.jcrs.2012.04.034. Epub 2012 Jul 15.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2009
Conclusão Primária (Real)
1 de dezembro de 2011
Conclusão do estudo (Real)
1 de dezembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
5 de abril de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de abril de 2013
Primeira postagem (Estimativa)
16 de abril de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de abril de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de abril de 2013
Última verificação
1 de abril de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças oculares
- Doenças do Sistema Endócrino
- Doenças das Lentes
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 2
- Catarata
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Inibidores da Ciclooxigenase
- Cetorolaco
Outros números de identificação do estudo
- 108-1080229-0142
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Ketorolac
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Chang Gung Memorial HospitalConcluído