Protein Profile of Immunoregulatory Factors in Diabetic Cataract

April 10, 2013 updated by: Danka Grcevic, University of Zagreb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Brodsko-posavska zupanija
      • Slavonski brod, Brodsko-posavska zupanija, Croatia, 35000
        • Department of Ophtalmology, General Hospital "Dr. J. Bencevic"
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Department of Physiology and Immunology, University of Zagreb School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: senile cataract with NSAID

15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation.

Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
Drug: Ketorolac
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.
Other Names:
  • Sprix
  • Toradol
  • Acular
Experimental: diabetic cataract with NSAID

17 diabetic patients undergoing phacoemulsification combined with IOL implantation.

Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.
Drug: Ketorolac
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.
Other Names:
  • Sprix
  • Toradol
  • Acular
No Intervention: senile cataract without NSAID

17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation.

Subgroup not receiving topical ketorolac.
No Intervention: diabetic cataract without NSAID

12 diabetic patients undergoing phacoemulsification combined with IOL implantation.

Subgroup not receiving topical ketorolac.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum level of interleukin-10
Time Frame: 2 hours before the surgery
2 hours before the surgery
serum level of monocyte chemotactic protein-1
Time Frame: 2 hours before the surgery
2 hours before the surgery
serum level of interleukin-17
Time Frame: 2 hours before the surgery
2 hours before the surgery
serum level of Fas ligand
Time Frame: 2 hours before the surgery
2 hours before the surgery
serum level of vascular endothelial growth factor
Time Frame: 2 hours before the surgery
2 hours before the surgery
level of interleukin-10 in aqueous humor
Time Frame: intraoperatively, at the start of the surgical procedure
intraoperatively, at the start of the surgical procedure
level of monocyte chemotactic protein-1 in aqueous humor
Time Frame: intraoperatively, at the start of the surgical procedure
intraoperatively, at the start of the surgical procedure
level of interleukin-17 in aqueous humor
Time Frame: intraoperatively, at the start of the surgical procedure
intraoperatively, at the start of the surgical procedure
level of Fas ligand in aqueous humor
Time Frame: intraoperatively, at the start of the surgical procedure
intraoperatively, at the start of the surgical procedure
level of vascular endothelial growth factor in aqueous humor
Time Frame: intraoperatively, at the start of the surgical procedure
intraoperatively, at the start of the surgical procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Investigators

  • Principal Investigator: Danka Grcevic, prof.,MD,PhD, University of Zagreb
  • Principal Investigator: Sanja Mitrovic, MD, Department of Ophthalmology, General Hospital "Dr. J. Bencevic"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108-1080229-0142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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