Protein Profile of Immunoregulatory Factors in Diabetic Cataract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danka Grcevic, University of Zagreb
ClinicalTrials.gov Identifier:
NCT01832311
First received: April 5, 2013
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Cataract
Type 2 Diabetes Mellitus
Drug: Ketorolac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • serum level of interleukin-10 [ Time Frame: 2 hours before the surgery ] [ Designated as safety issue: No ]
  • serum level of monocyte chemotactic protein-1 [ Time Frame: 2 hours before the surgery ] [ Designated as safety issue: No ]
  • serum level of interleukin-17 [ Time Frame: 2 hours before the surgery ] [ Designated as safety issue: No ]
  • serum level of Fas ligand [ Time Frame: 2 hours before the surgery ] [ Designated as safety issue: No ]
  • serum level of vascular endothelial growth factor [ Time Frame: 2 hours before the surgery ] [ Designated as safety issue: No ]
  • level of interleukin-10 in aqueous humor [ Time Frame: intraoperatively, at the start of the surgical procedure ] [ Designated as safety issue: No ]
  • level of monocyte chemotactic protein-1 in aqueous humor [ Time Frame: intraoperatively, at the start of the surgical procedure ] [ Designated as safety issue: No ]
  • level of interleukin-17 in aqueous humor [ Time Frame: intraoperatively, at the start of the surgical procedure ] [ Designated as safety issue: No ]
  • level of Fas ligand in aqueous humor [ Time Frame: intraoperatively, at the start of the surgical procedure ] [ Designated as safety issue: No ]
  • level of vascular endothelial growth factor in aqueous humor [ Time Frame: intraoperatively, at the start of the surgical procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • degree of corneal edema [ Time Frame: preoperatively - 2 hours before the surgery ] [ Designated as safety issue: No ]
  • degree of corneal edema [ Time Frame: postoperatively - day 1 ] [ Designated as safety issue: No ]
  • degree of corneal edema [ Time Frame: postoperatively - day 8 ] [ Designated as safety issue: No ]
  • degree of corneal edema [ Time Frame: postoperatively - week 3 ] [ Designated as safety issue: No ]
  • degree of corneal edema [ Time Frame: postoperatively - month 3 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Toradol
  • Acular
  • Sprix
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:
  • Toradol
  • Acular
  • Sprix
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.


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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832311

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

Publications:

Responsible Party: Danka Grcevic, prof. Danka Grcevic, MD, PhD, University of Zagreb
ClinicalTrials.gov Identifier: NCT01832311     History of Changes
Other Study ID Numbers: 108-1080229-0142
Study First Received: April 5, 2013
Last Updated: April 10, 2013
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Zagreb:
type 2 diabetes mellitus
cataract
cytokines
chemokines
aqueous humor

Additional relevant MeSH terms:
Cataract
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lens Diseases
Eye Diseases
Anti-Inflammatory Agents
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014