Protein Profile of Immunoregulatory Factors in Diabetic Cataract
10 april 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
61
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Brodsko-posavska zupanija
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Slavonski brod, Brodsko-posavska zupanija, Kroatien, 35000
- Department of Ophtalmology, General Hospital "Dr. J. Bencevic"
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Grad Zagreb
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Zagreb, Grad Zagreb, Kroatien, 10000
- Department of Physiology and Immunology, University of Zagreb School of Medicine
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
|
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Experimentell: 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.
Andra namn:
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Inget ingripande: senile cataract without NSAID
17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. |
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Inget ingripande: diabetic cataract without NSAID
12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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serum level of interleukin-10
Tidsram: 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
Tidsram: 2 hours before the surgery
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2 hours before the surgery
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serum level of interleukin-17
Tidsram: 2 hours before the surgery
|
2 hours before the surgery
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serum level of Fas ligand
Tidsram: 2 hours before the surgery
|
2 hours before the surgery
|
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serum level of vascular endothelial growth factor
Tidsram: 2 hours before the surgery
|
2 hours before the surgery
|
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level of interleukin-10 in aqueous humor
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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degree of corneal edema
Tidsram: preoperatively - 2 hours before the surgery
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preoperatively - 2 hours before the surgery
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degree of corneal edema
Tidsram: postoperatively - day 1
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postoperatively - day 1
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degree of corneal edema
Tidsram: postoperatively - day 8
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postoperatively - day 8
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degree of corneal edema
Tidsram: postoperatively - week 3
|
postoperatively - week 3
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degree of corneal edema
Tidsram: postoperatively - month 3
|
postoperatively - month 3
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Danka Grcevic, prof.,MD,PhD, University of Zagreb
- Huvudutredare: Sanja Mitrovic, MD, Department of Ophthalmology, General Hospital "Dr. J. Bencevic"
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- 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.
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- 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.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2009
Primärt slutförande (Faktisk)
1 december 2011
Avslutad studie (Faktisk)
1 december 2012
Studieregistreringsdatum
Först inskickad
5 april 2013
Först inskickad som uppfyllde QC-kriterierna
10 april 2013
Första postat (Uppskatta)
16 april 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 april 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 april 2013
Senast verifierad
1 april 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Ögonsjukdomar
- Sjukdomar i det endokrina systemet
- Linssjukdomar
- Diabetes mellitus
- Diabetes mellitus, typ 2
- Grå starr
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel, icke-steroida
- Analgetika, icke-narkotiska
- Antiinflammatoriska medel
- Antireumatiska medel
- Cyklooxygenashämmare
- Ketorolac
Andra studie-ID-nummer
- 108-1080229-0142
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