Protein Profile of Immunoregulatory Factors in Diabetic Cataract

University of Zagreb

Status and phase: Completed; Phase 4

Conditions: Cataract; Type 2 Diabetes Mellitus

Treatments: Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT01832311

108-1080229-0142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

senile cataract with NSAID

Experimental group

Description:

15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.

Treatment:

Drug: Ketorolac

diabetic cataract with NSAID

Experimental group

Description:

17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.

Treatment:

Drug: Ketorolac

senile cataract without NSAID

No Intervention group

Description:

17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.

diabetic cataract without NSAID

No Intervention group

Description:

12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.