Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Phase 4

Completed

• Conditions: Cataract; Type 2 Diabetes Mellitus
• Interventions: Drug: Ketorolac

• Registration Number: NCT01832311
• Lead Sponsor: University of Zagreb

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Study First Posted: 2013-04-16
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetic cataract with NSAID	Ketorolac	17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
senile cataract with NSAID	Ketorolac	15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
degree of corneal edema	postoperatively - month 3

Trial Locations

Locations (2)

Department of Physiology and Immunology, University of Zagreb School of Medicine; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Department of Ophtalmology, General Hospital "Dr. J. Bencevic"; 🇭🇷 Slavonski brod, Brodsko-posavska zupanija, Croatia