Cataract, Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes mellitus, cataract, cytokines, chemokines, aqueous humor
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetorolac
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.
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| level of vascular endothelial growth factor in aqueous humor | intraoperatively, at the start of the surgical procedure |
| serum level of interleukin-10 | 2 hours before the surgery |
| serum level of monocyte chemotactic protein-1 | 2 hours before the surgery |
| serum level of interleukin-17 | 2 hours before the surgery |
| serum level of Fas ligand | 2 hours before the surgery |
| serum level of vascular endothelial growth factor | 2 hours before the surgery |
| level of interleukin-10 in aqueous humor | intraoperatively, at the start of the surgical procedure |
| level of monocyte chemotactic protein-1 in aqueous humor | intraoperatively, at the start of the surgical procedure |
| level of interleukin-17 in aqueous humor | intraoperatively, at the start of the surgical procedure |
| level of Fas ligand in aqueous humor | intraoperatively, at the start of the surgical procedure |
Secondary
| Measure | Time frame |
|---|---|
| degree of corneal edema | preoperatively - 2 hours before the surgery |
Countries
Croatia
Outcome results
None listed