Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Study Overview
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Brief Summary
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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
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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.

Official Title
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Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Conditions
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Cataract, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: senile cataract with NSAID<br>15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac. | Drug: Ketorolac<br>* 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.<br>* Other names: Sprix;|
| Experimental: diabetic cataract with NSAID<br>17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac. | Drug: Ketorolac<br>* 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.<br>* Other names: Sprix;|
| No Intervention: senile cataract without NSAID<br>17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. | |
| No Intervention: diabetic cataract without NSAID<br>12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| level of vascular endothelial growth factor in aqueous humor |  | intraoperatively, at the start of the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of corneal edema |  | preoperatively - 2 hours before the surgery | 
| degree of corneal edema |  | postoperatively - day 1 | 
| degree of corneal edema |  | postoperatively - day 8 | 
| degree of corneal edema |  | postoperatively - week 3 | 
| degree of corneal edema |  | postoperatively - month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, cataract, cytokines, chemokines, aqueous humor