A Phase 4 interventional study of Ketorolac in Cataract and Type 2 Diabetes Mellitus, sponsored by University of Zagreb. Completed at 2 sites in Croatia. Per ClinicalTrials.gov, last updated 2013-04-16.
Sponsored by University of Zagreb · Phase 4, Interventional, and Supportive care
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →University of Zagreb is the lead sponsor of 67 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
Drug: Ketorolac
17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
Drug: Ketorolac
17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.
12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical 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.
Also known as: Toradol, Acular, Sprix
serum level of interleukin-10
Time frame: 2 hours before the surgery
serum level of monocyte chemotactic protein-1
Time frame: 2 hours before the surgery
serum level of interleukin-17
Time frame: 2 hours before the surgery
serum level of Fas ligand
Time frame: 2 hours before the surgery
serum level of vascular endothelial growth factor
Time frame: 2 hours before the surgery
level of interleukin-10 in aqueous humor
Time frame: intraoperatively, at the start of the surgical procedure
level of monocyte chemotactic protein-1 in aqueous humor
Time frame: intraoperatively, at the start of the surgical procedure
level of interleukin-17 in aqueous humor
Time frame: intraoperatively, at the start of the surgical procedure
level of Fas ligand in aqueous humor
Time frame: intraoperatively, at the start of the surgical procedure
level of vascular endothelial growth factor in aqueous humor
Time frame: intraoperatively, at the start of the surgical procedure
degree of corneal edema
Time frame: preoperatively - 2 hours before the surgery
degree of corneal edema
Time frame: postoperatively - day 1
degree of corneal edema
Time frame: postoperatively - day 8
degree of corneal edema
Time frame: postoperatively - week 3
degree of corneal edema
Time frame: postoperatively - month 3
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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University of Zagreb