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Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Primary Purpose

Cataract, Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Croatia

Study Type

Interventional

Intervention

Ketorolac

About this trial

This is an interventional supportive care trial for Cataract focused on measuring type 2 diabetes mellitus, cataract, cytokines, chemokines, aqueous humor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Department of Ophtalmology, General Hospital "Dr. J. Bencevic"
Department of Physiology and Immunology, University of Zagreb School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

senile cataract with NSAID

diabetic cataract with NSAID

senile cataract without NSAID

diabetic cataract without NSAID

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum level of interleukin-10

serum level of monocyte chemotactic protein-1

serum level of interleukin-17

serum level of Fas ligand

serum level of vascular endothelial growth factor

level of interleukin-10 in aqueous humor

level of monocyte chemotactic protein-1 in aqueous humor

level of interleukin-17 in aqueous humor

level of Fas ligand in aqueous humor

level of vascular endothelial growth factor in aqueous humor

Secondary Outcome Measures

degree of corneal edema

Full Information

NCT ID

NCT01832311

First Posted

April 5, 2013

Last Updated

April 10, 2013

Sponsor

University of Zagreb

1. Study Identification

Unique Protocol Identification Number

NCT01832311

Brief Title

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Official Title

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Zagreb

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus, cataract, cytokines, chemokines, aqueous humor

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

senile cataract with NSAID

Arm Type

Experimental

Arm Description

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

Arm Title

diabetic cataract with NSAID

Arm Type

Experimental

Arm Description

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

Arm Title

senile cataract without NSAID

Arm Type

No Intervention

Arm Description

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

Arm Title

diabetic cataract without NSAID

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketorolac

Other Intervention Name(s)

Toradol, Acular, Sprix

Intervention Description

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.

Primary Outcome Measure Information:

Title

serum level of interleukin-10

Time Frame

2 hours before the surgery

Title

serum level of monocyte chemotactic protein-1

Time Frame

2 hours before the surgery

Title

serum level of interleukin-17

Time Frame

2 hours before the surgery

Title

serum level of Fas ligand

Time Frame

2 hours before the surgery

Title

serum level of vascular endothelial growth factor

Time Frame

2 hours before the surgery

Title

level of interleukin-10 in aqueous humor

Time Frame