Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Sponsor

University of Zagreb (Other)

Overall Status

Completed

CT.gov ID

NCT01832311

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

30.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Type 2 Diabetes Mellitus	Drug: Ketorolac	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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: 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.

Outcome Measures

Primary Outcome Measures

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

degree of corneal edema [preoperatively - 2 hours before the surgery]
degree of corneal edema [postoperatively - day 1]
degree of corneal edema [postoperatively - day 8]
degree of corneal edema [postoperatively - week 3]
degree of corneal edema [postoperatively - month 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophtalmology, General Hospital "Dr. J. Bencevic"	Slavonski brod	Brodsko-posavska zupanija	Croatia	35000
2	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"